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REMEL, INC.

United States·US-MF-000044686

Last updated September 17, 2026

Information

Country: United States
Address: 12076, Santa Fe Trail Drive, Lenexa, Kansas, United States
Website: www.thermofisher.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8002556730
PRRC Contact: Paul Sherlock
EUDAMED SRN: US-MF-000044686
FDA FEI Number: 1924669
DUNS Number: 065769564

Catalogue (1212)

Page 23 of 25

Device	Model / Reference	Registries	Class	Status
A3b	K834065	FDA 510(k)	Class I	Active
Ala Swab	K801493	FDA 510(k)	Class I	Active
Synergy Quad	K941443	FDA 510(k)	Class II	Active
Ef Synergy Quad	K903589	FDA 510(k)	Class II	Active
Remel Cefaclor 30mcg Susceptibility Disk	K924846	FDA 510(k)	Class II	Active
Beta Lysin Disk	K810541	FDA 510(k)	Class I	Active
Bio-Ornithine	K834028	FDA 510(k)	Class I	Active
Bactidrop Indole (erlich's)	K920973	FDA 510(k)	Class I	Active
Cva	K833967	FDA 510(k)	Class I	Active
10b	K833968	FDA 510(k)	Class I	Active
Ceb	K834068	FDA 510(k)	Class I	Active
Buffered Charcoal Yeast Extract Agar	K802757	FDA 510(k)	Class I	Active
Hemastaph	K840553	FDA 510(k)	Class I	Active
Remel Lomefloxacin 10 Mcg Susceptibility Disk	K924765	FDA 510(k)	Class II	Active
Slide Culture Plate-Potato Flake Agar	K880716	FDA 510(k)	Class I	Active
Nitrate Swab-Rapid Test	K800803	FDA 510(k)	Class I	Active
Remel Spectra ESBL	K162620	FDA 510(k)	Class II	Active
Bactidrop(tm) Mucap	K930878	FDA 510(k)	Class I	Active
Prospect Clostridium Difficile Toxin A/B Microplate Assay	K033479	FDA 510(k)	Class I	Active
Strep Selective Ii	K843193	FDA 510(k)	Class I	Active
Porphyrin (ala) Disk	K801492	FDA 510(k)	Class I	Active
Haemophilus Test Medium (agar)	K892928	FDA 510(k)	Class II	Active
Bactidrop Calcofluor White	K920975	FDA 510(k)	Class I	Active
Caffeic Acid Disk	K850194	FDA 510(k)	Class I	Active
Par-One	K981391	FDA 510(k)	Class I	Active
Bactidrop(tm) Ferric Chloride (10%)	K913002	FDA 510(k)	Class I	Active
Bio-Urea	K834029	FDA 510(k)	Class I	Active
Remel Xpect Flu A&B	K131804	FDA 510(k)	Class I	Active
Rpmi 1640 Agar W/Mops And 2% Glucose	K072827	FDA 510(k)	Class II	Active
Legionella Differentiation Disk	K834067	FDA 510(k)	Class II	Active
Bactidrop Acridine Orange	K920974	FDA 510(k)	Class II	Active
Remel Azithromlycin 15 Mcg Susceptibility Disk	K933657	FDA 510(k)	Class II	Active
Bactidrop(tm) Nitrate A	K913011	FDA 510(k)	Class I	Active
Macconkey W/Mug	K861259	FDA 510(k)	Class I	Active
Cye Biphasic Blood Culture Medium	K802571	FDA 510(k)	Class I	Active
Ef Synergy Quad Modified	K910242	FDA 510(k)	Class II	Active
Pyr Broth	K843987	FDA 510(k)	Class I	Active
Novobiocin Disc	K840483	FDA 510(k)	Class I	Active
Remel Clarithromycin 15 Mcg Susceptibility Disk	K933118	FDA 510(k)	Class II	Active
Urea-Pda Disk	K830396	FDA 510(k)	Class I	Active
Porphyrin Test Agar	K840685	FDA 510(k)	Class I	Active
Indoxyl Acetate Disk	K923700	FDA 510(k)	Class I	Active
Tomtec Gram Stainer Decolorizer	K871533	FDA 510(k)	Class I	Active
Bacti-Swab(tm) Npg	K912832	FDA 510(k)	Class I	Active
Buffered Cye Agar Deep W/Supplements	K840890	FDA 510(k)	Class I	Active
Remel Cefprozil 30 Mcg Susceptibility Disk	K934100	FDA 510(k)	Class II	Active
Bactidrop(tm) Spot Indole	K913004	FDA 510(k)	Class I	Active
Thermonuclease Agar W/Toluidine Blue	K864205	FDA 510(k)	Class I	Active
Tb Susceptibility Quads I And Ii	K920143	FDA 510(k)	Class II	Active
Rapid Nitrate B Reagent	R8309004	EUDAMEDFDA UDI	Class A	Active

Related Companies

Authorised Representatives

Thermo Fisher Diagnostics B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 24, 2026	Z-1806-2026	—	open, classified	Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Feb 5, 2026	Z-1474-2026	—	open, classified	Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
Nov 12, 2025	Z-0585-2026	—	open, classified	Products may contain contamination, which may result in a darker or brown media color.
Jul 11, 2025	Z-2224-2025	—	open, classified	The products may contain surface and subsurface contamination of Listeria monocytogenes.
Jul 11, 2025	Z-2226-2025	—	open, classified	The products may contain surface and subsurface contamination of Listeria monocytogenes.
Jul 11, 2025	Z-2225-2025	—	open, classified	The products may contain surface and subsurface contamination of Listeria monocytogenes.
Jul 11, 2025	Z-2223-2025	—	open, classified	The products may contain surface and subsurface contamination of Listeria monocytogenes.
May 1, 2025	Z-1947-2025	—	open, classified	Product may have an off color affecting perfomance
Feb 13, 2025	Z-1200-2025	—	open, classified	Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Feb 13, 2025	Z-1201-2025	—	open, classified	Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Feb 12, 2025	Z-1395-2025	—	open, classified	Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Sep 20, 2024	Z-0266-2025	—	open, classified	A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
Aug 14, 2023	Z-2531-2023	—	open, classified	On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
May 31, 2023	Z-2038-2023	—	open, classified	The test medium may not perform as intended.
Oct 20, 2022	Z-0332-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0327-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0335-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0333-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0334-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0331-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0330-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0328-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Oct 20, 2022	Z-0329-2023	—	terminated	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
Jan 10, 2022	Z-0722-2022	—	open, classified	There are lower than expected MICs for some gram negative species.
Jun 18, 2021	Z-2142-2021	—	terminated	Out of Specification
Apr 22, 2021	Z-1561-2021	—	terminated	The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Mar 10, 2021	Z-1424-2021	—	open, classified	When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Mar 10, 2021	Z-1425-2021	—	open, classified	When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Dec 10, 2020	Z-0769-2021	—	terminated	The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Apr 17, 2019	Z-1380-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Apr 17, 2019	Z-1377-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Apr 17, 2019	Z-1400-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1403-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1404-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1379-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Apr 17, 2019	Z-1401-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1408-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1406-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1409-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1378-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Apr 17, 2019	Z-1405-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1402-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Apr 17, 2019	Z-1407-2019	—	terminated	Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Jan 4, 2019	Z-1939-2020	—	terminated	Potential for out of range microbial results
Aug 13, 2018	Z-3019-2018	—	terminated	Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Aug 13, 2018	Z-3017-2018	—	terminated	Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Aug 13, 2018	Z-3018-2018	—	terminated	Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Dec 8, 2017	Z-0290-2018	—	terminated	The serum may fail to agglutinate within the specified minimum reaction time.
Nov 2, 2017	Z-0209-2018	—	terminated	Product may have incorrect cation information detailed on the product label.
Mar 24, 2017	Z-1888-2017	—	terminated	Confirmed complaint of surface contamination of Listeria monocytogenes.
Feb 9, 2017	Z-1400-2017	—	terminated	Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Mar 24, 2016	Z-1921-2016	—	terminated	Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
Nov 6, 2015	Z-0443-2016	—	terminated	Antibiotic concentration may be insufficient which may result in incorrect test results.
Jun 30, 2015	Z-2350-2015	—	terminated	A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Jun 30, 2015	Z-2351-2015	—	terminated	A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
May 19, 2015	Z-1841-2015	—	terminated	Use of the recalled product may result in false positive reports.
May 19, 2015	Z-1842-2015	—	terminated	Use of the recalled product may result in false positive reports.
May 4, 2015	Z-1748-2015	—	terminated	Product may be contaminated with Listeria monocytogenes.
Feb 5, 2015	Z-1232-2015	—	terminated	Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
Nov 13, 2014	Z-0578-2015	—	terminated	Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
Oct 29, 2014	Z-0449-2015	—	terminated	The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Oct 23, 2014	Z-0466-2015	—	terminated	A reagent within the test may return false negative results.
Oct 23, 2014	Z-0465-2015	—	terminated	A reagent within the test may return false negative results.
Oct 17, 2014	Z-0200-2015	—	terminated	Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
Jun 11, 2014	Z-2057-2014	—	terminated	Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Mar 17, 2014	Z-1473-2014	—	terminated	A reagent contained within the product may return false negative results.
Mar 17, 2014	Z-1474-2014	—	terminated	A reagent contained within the product may return false negative results.
Feb 18, 2014	Z-1246-2014	—	terminated	Some of the discs may not be impregnated with the antibiotic.
Jan 24, 2014	Z-1112-2014	—	terminated	The product may contain high levels of microbial contamination
Nov 21, 2013	Z-0734-2014	—	terminated	Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
May 2, 2013	Z-0538-2014	—	terminated	The product may give weak or false negative test results.
May 2, 2013	Z-0537-2014	—	terminated	The product may give weak or false negative test results.
Apr 9, 2013	Z-0795-2014	—	terminated	Cartridges may contain individual discs which were not impregnated with antibiotic.
Apr 9, 2013	Z-0793-2014	—	terminated	Cartridges may contain individual discs which were not impregnated with antibiotic.
Apr 9, 2013	Z-0794-2014	—	terminated	Cartridges may contain individual discs which were not impregnated with antibiotic.
Apr 9, 2013	Z-0792-2014	—	terminated	Cartridges may contain individual discs which were not impregnated with antibiotic.
Apr 4, 2013	Z-0530-2014	—	terminated	The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Mar 25, 2013	Z-2081-2013	—	terminated	Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Feb 19, 2013	Z-1962-2013	—	terminated	Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Nov 21, 2012	Z-0528-2014	—	terminated	Boxes labeled as CIP5 may contain cartridges of AMP5.
Oct 10, 2012	Z-0801-2013	—	terminated	The product may contain low level microbial contamination which could result in incorrect results.
Aug 21, 2012	Z-0808-2013	—	terminated	The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Aug 21, 2012	Z-0790-2013	—	terminated	The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
Aug 20, 2012	Z-0806-2013	—	terminated	The firm is recalling the products due to a potential for false negative test results.
Aug 20, 2012	Z-0807-2013	—	terminated	The firm is recalling the products due to a potential for false negative test results.
May 11, 2011	Z-2677-2011	—	terminated	The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
Apr 21, 2011	Z-2928-2011	—	terminated	Organism strains may fail to consistently produce confluent growth
Apr 21, 2011	Z-2929-2011	—	terminated	Organism strains may fail to consistently produce confluent growth
Jan 18, 2010	Z-1139-2010	—	terminated	Pouch may be inadequately heat sealed compromising sterility
Dec 21, 2009	Z-0979-2010	—	terminated	Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
Dec 8, 2009	Z-0644-2010	—	terminated	The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
Oct 28, 2009	Z-0870-2010	—	terminated	There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and Candida dubliniensis. When using the
Jul 20, 2009	Z-0817-2010	—	terminated	The products may give false positive results with some non-Staphylococcus aureus strains
Jul 20, 2009	Z-0818-2010	—	terminated	The products may give false positive results with some non-Staphylococcus aureus strains
May 7, 2009	Z-1812-2009	—	terminated	Incorrect expiration date on the product
May 6, 2009	Z-1733-2009	—	terminated	The plate labeling is incorrect, but the outer box labeling is correct
Nov 18, 2008	Z-1400-2009	—	terminated	These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.
Oct 7, 2008	Z-1008-2009	—	terminated	Control and test wells are reversed on some of the reaction cards.
Aug 11, 2008	Z-2432-2008	—	terminated	Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive
Oct 23, 2007	Z-1624-2008	—	terminated	Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.