Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgG kits due to incorrect package inserts indicating use with plasma, serum, and other fluids. Kits should only be used with plasma for accurate heparin-dependent antibody detection.
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 MonoStrip IgG kits because the package inserts incorrectly state they can be used with plasma, serum, or other biological fluids. The kits should only be used with plasma to avoid inaccurate results.
The kits are designed to detect heparin-dependent antibodies in human plasma. If used with serum or other biological fluids, the test results may be inaccurate due to the incorrect package instructions.
Clinical laboratory users who have the ZYMUTEST HIA MonoStrip IgG kits with lot numbers F1701084P2 or F1701084P3 are likely affected. Those using the kits with non-plasma samples risk inaccurate test results.
Check for the ZYMUTEST HIA MonoStrip IgG kits with lot numbers F1701084P2 or F1701084P3. The kits are sold under the reference number RK041A and have a unique identifier UDI: 03663537046803.
Look for lot numbers F1701084P2 or F1701084P3 on the product packaging.
The package inserts incorrectly state the kits can be used with plasma, serum, and other biological fluids. The kits should only be used with plasma for accurate heparin-dependent antibody detection.
Check the lot number on your kit. If it's F1701084P2 or F1701084P3, you should stop using it and contact Hyphen BioMed for guidance.
No, the kits should only be used with plasma. Using them with serum or other biological fluids may cause inaccurate test results.
We’ve drafted a message you can send Hyphen BioMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1742-2018 — Hyphen BioMed Hyphen BioMed Hello, I own a Hyphen BioMed that is covered by recall Z-1742-2018 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.
