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ZYMUTEST HIA IgG

HYPHEN BIOMED · Model RK040A · UDI-DI 03663537018763

LCO
1
510(k) clearances
31
Adverse events (1 deaths)
13
Recalls
7
Facilities

Recalls

DateFirmReason
2026-09-03Instrumentation LaboratoryPotential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
2026-09-03Instrumentation LaboratoryPotential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
2026-04-01Aniara Diagnostica LLCKits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
2025-12-15Diagnostica Stago, Inc.Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
2019-07-19Aniara Diagnostica LLCResidual crystallization of the microplate and recurrent negative controls out of range.
2019-07-19Aniara Diagnostica LLCResidual crystallization of the microplate and recurrent negative controls out of range.
2018-02-05Hyphen BioMedIncorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
2018-02-05Hyphen BioMedIncorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
2018-02-05Hyphen BioMedIncorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
2014-12-15Genetic Testing Institute,incSome 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

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Data 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.