Diamedix Corp.
United StatesFDA applicant, unverified
Diamedix Corp. is a medical device manufacturer, with 116 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) and 14 FDA recalls as of 14 Nov 2026.
- Devices
- 116
- FDA recalls
- 14
Registry facts
- Registries
- FDA 510(k) 68
- FDA GUDID 48
- Device classes
- FDA Class II 94
- FDA Class I 22
- FDA recalls
At a glance
Market reach
- United States
- FDA recalls
What Diamedix Corp. makes
Diamedix Corp. manufactures in vitro diagnostic (IVD) kits and controls for detecting specific antibodies and proteins, including measles virus IgG (complement fixation), Echinococcus IgG (enzyme immunoassay), Cryptosporidium parvum IgG (immunoblot), Candida species IgA/IgG/IgM (enzyme immunoassay), and Candida albicans IgM (enzyme immunoassay). The company also produces a multichannel clinical chemistry analyser designed for point-of-care use with line power.
The company’s products are regulated under FDA 510(k) and UDI requirements, with devices classified as Class I and Class II.
Catalogue
Search and filter all 116 devicesShowing 1-50 of 116
FDA recalls
FDA recall records list 14 recalls initiated by Diamedix Corp., the earliest on 2003-09-11 and the most recent on 2018-01-05. By recorded status: 14 terminated. The reasons filed fall into these groups: labeling or instructions for use, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 5 Jan 2018 Z-2573-2018 Class III Terminated Contains a gel-like contaminant that may affect product performance.
- 5 Jan 2018 Z-2574-2018 Class III Terminated Contains a gel-like contaminant that may affect product performance.
2015
- 26 Mar 2015 Z-1689-2016 Class II Terminated Product contained an incorrect substrate.
2014
- 20 Oct 2014 Z-1685-2016 Class II Terminated A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Full distribution text
- 20 Oct 2014 Z-1686-2016 Class II Terminated A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Full distribution text
- 20 Oct 2014 Z-1687-2016 Class II Terminated A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
Full distribution text
- 20 Oct 2014 Z-1685-2016 Class II Terminated A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
2012
- 6 Aug 2012 Z-0445-2013 Class II Terminated Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Full distribution text
- 16 Jan 2012 Z-1520-2012 Not yet classified Terminated On 01/16/20112 Diamedix initiated a recall of IS-HSV 1&2 IgM Test Kit, Catalog # 720-350, Lot 60701, Exp. June 30, 2012. The Positive Control for this lot is Out of Specification.
- 6 Aug 2012 Z-0445-2013 Class II Terminated Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
2011
- 8 Jun 2011 Z-1620-2012 Unclassified (pre-2012) Terminated On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
Full distribution text
- 8 Jun 2011 Z-1620-2012 Unclassified (pre-2012) Terminated On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit, Catalog # 720-320 Master Lot S0000, Exp. Date May 31, 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
2008
- 10 Oct 2008 Z-0607-2009 Unclassified (pre-2012) Terminated Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
Show all 14 recalls
2008
- 21 Mar 2008 Z-1684-2008 Unclassified (pre-2012) Terminated Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the test), or false positive test results could be obtained.
2004
- 23 Dec 2004 Z-0541-05 Unclassified (pre-2012) Terminated The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.
2003
- 9 Dec 2003 Z-0513-04 Unclassified (pre-2012) Terminated The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
- 11 Sep 2003 Z-0325-05 Unclassified (pre-2012) Terminated Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
Frequently asked questions
How many devices does Diamedix Corp. have in the registry?
The registry currently lists 116 devices for Diamedix Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diamedix Corp.'s devices?
Among its 50 most recently registered devices, Diamedix Corp. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Diamedix Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Diamedix Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Diamedix Corp.?
FDA recall records list 14 recalls initiated by Diamedix Corp., the most recent initiated on 5 Jan 2018. 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 Diamedix Corp. in the registry?
The most recently registered devices listed for Diamedix Corp. include Diamedix 720-380, Diamedix 789-008, Diamedix 720-250 and Diamedix 720-540.