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ZYMUTEST HIA IgG
HYPHEN BIOMED · Model RK040A · UDI-DI 03663537018763
1
510(k) clearances
22
Adverse events (1 deaths)
11
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-01 | Aniara Diagnostica LLC | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. |
| 2025-12-15 | Diagnostica Stago, Inc. | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. |
| 2019-07-19 | Aniara Diagnostica LLC | Residual crystallization of the microplate and recurrent negative controls out of range. |
| 2019-07-19 | Aniara Diagnostica LLC | Residual crystallization of the microplate and recurrent negative controls out of range. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2018-02-05 | Hyphen BioMed | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| 2014-12-15 | Genetic Testing Institute,inc | Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background |
| 2013-02-04 | Genetic Testing Institute,inc | Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. Th |
| 2011-11-09 | Hyphen BioMed | A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false posi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.