Phadia US Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3004973408
- Devices
- 22
- Registrations
- FDA
- FDA recalls
- 102 ongoing
Catalogue
Search and filter all 22 devicesCompany details
- FDA FEI number
- 3004973408
- Address
- 4169 COMMERCIAL AVE., Portage, MI, 49002
FDA recalls
Recalls initiated per year
- 2017 4
- 2018 0
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 1 May 2023 Z-2040-2023 Class II Ongoing Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
- 1 May 2023 Z-2041-2023 Class II Ongoing Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
2020
- 14 Dec 2020 Z-1107-2021 Class II Terminated Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
2017
- 18 Dec 2017 Z-1312-2018 Class II Terminated The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
- 18 Dec 2017 Z-1313-2018 Class II Terminated The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
- 5 Jul 2017 Z-0387-2018 Class II Terminated The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
- 30 Jan 2017 Z-1253-2017 Class II Terminated Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
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2014
- 20 Nov 2014 Z-0947-2015 Class II Terminated During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Full distribution text
- 20 Nov 2014 Z-0947-2015 Class II Terminated During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
2012
- 2 Aug 2012 Z-2285-2012 Class III Terminated Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
- 3 Jan 2012 Z-1055-2012 Not yet classified Terminated The firm found this lot of ImmunoCAP Allergen Ri206, American Cockroach does not contain sufficient levels of some cockroach allergens e.g. tropomyosin. Approximately 2% of the positive samples have a risk to fall below the Limit of Quantization (o .1 kUA/L).
Frequently asked questions
How many devices does PHADIA US INC. have in the registry?
The registry currently lists 22 devices for PHADIA US INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list PHADIA US INC.'s devices?
Among its 22 most recently registered devices, PHADIA US INC. has devices listed in FDA 510(k) (22 devices).
What risk classes do PHADIA US INC.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for PHADIA US INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for PHADIA US INC.?
FDA recall records list 10 recalls initiated by PHADIA US INC., the most recent initiated on 1 May 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from PHADIA US INC. in the registry?
The most recently registered devices listed for PHADIA US INC. include EIA SMDP IMMUNOASSAY, RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM, IMMUNOCAP THYRLOBULIN IMMUNOCAP and ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO.