Hyphen BioMed recalls ZYMUTEST HIA IgGAM kits due to incorrect package instructions. Kits should only be used with plasma, not serum or other fluids. Affected kits have specific lot numbers.
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Hyphen BioMed is recalling ZYMUTEST HIA IgGAM kits because the package instructions incorrectly state they can be used with serum and other biological fluids. The kits should only be used with plasma to avoid potential errors in heparin-dependent antibody testing.
The kits are designed to detect heparin-dependent antibodies in human plasma. If used with serum or other fluids instead of plasma, the test results may be inaccurate, leading to incorrect diagnoses or treatment decisions.
Clinical laboratory users who purchased the affected ZYMUTEST HIA IgGAM kits with lot numbers F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, or F1701369P2 are most at risk. These kits were sold globally for heparin-dependent antibody testing.
Check the lot numbers on the kit packaging: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, or F1701369P2. The kits are labeled as ZYMUTEST HIA IgGAM with REF Number RK040D and UDI 03663537018770.
Look for the lot numbers F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, or F1701369P2 on the packaging.
The package instructions incorrectly state that the kits can be used with serum and other biological fluids. The kits should only be used with plasma to ensure accurate heparin-dependent antibody testing.
Check the lot numbers on the packaging. If you have the affected lot numbers, you should stop using the kits and contact Hyphen BioMed for guidance.
Using the kits with serum or other fluids instead of plasma may lead to inaccurate test results, which could affect diagnosis and treatment decisions.
We’ve drafted a message you can send Hyphen BioMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1744-2018 — Hyphen BioMed Hyphen BioMed Hello, I own a Hyphen BioMed that is covered by recall Z-1744-2018 from Hyphen BioMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
