Hyphen BioMed recalls ZYMUTEST HIA MonoStria kits for heparin-dependent antibody testing due to incorrect package instructions about plasma use. Affected kits should only be used with plasma, not serum or other fluids.
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 MonoStria antibody testing kits because the package instructions incorrectly say they can be used with serum or other fluids instead of plasma. This could lead to inaccurate test results if the kits are used incorrectly.
The kits are designed to detect heparin-dependent antibodies in human plasma only. Using them with serum or other fluids instead of plasma can cause inaccurate test results because the test requires specific plasma conditions.
Clinical laboratory users who purchased the ZYMUTEST HIA MonoStria kits with lot numbers F1600568P1, F1701370P1, or F1701370P2. Those using the kits with serum or other fluids instead of plasma are at risk of inaccurate test results.
Check for lot numbers F1600568P1, F1701370P1, or F1701370P2 on the packaging. The kits are intended for use with plasma only, not serum or other biological fluids.
Look for lot numbers F1600568P1, F1701370P1, or F1701370P2 on the packaging to confirm if the kit is affected.
Ensure the kit is used only with plasma, not serum or other biological fluids, to avoid inaccurate test results.
The package instructions incorrectly state the kits can be used with serum or other fluids instead of plasma, which could lead to inaccurate test results.
Check the lot number on the packaging. If it's F1600568P1, F1701370P1, or F1701370P2, use the kits only with plasma to avoid inaccurate results.
Yes, but only if you use them with plasma and not serum or other fluids. Using them with the wrong fluid type could 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-1743-2018 — Hyphen BioMed Hyphen BioMed Hello, I own a Hyphen BioMed that is covered by recall Z-1743-2018 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.
