Diagnostica Stago recalls Asserachrom HPIA kit model 00615 with lot 271288 due to potential false negative results in heparin-induced thrombocytopenia testing. Affected kits may not detect anti-heparin-platelet factor 4 antibodies correctly.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Diagnostica Stago is recalling Asserachrom HPIA test kits with lot number 271288 because they may produce false negative results for heparin-induced thrombocytopenia (HIT type II) testing. This could lead to incorrect health conclusions if the test is used for this purpose.
The kit may produce false negative results for anti-heparin-platelet factor 4 antibodies in plasma or serum. This means the test might incorrectly show no antibodies when they are actually present, potentially missing a serious blood clotting condition.
People who use Asserachrom HPIA kits with lot number 271288 for heparin-induced thrombocytopenia testing may be affected. Those with HIT type II who rely on this test for diagnosis are at higher risk of incorrect results.
Check the lot number on the kit, which is 271288. The product is labeled as Asserachrom HPIA with model number 00615. It was sold for qualitative detection of HIT type II antibodies.
Look for the lot number 271288 on the Asserachrom HPIA kit packaging.
The kit may produce false negative results for anti-heparin-platelet factor 4 antibodies in heparin-induced thrombocytopenia testing, which could lead to incorrect health conclusions.
Check the lot number on the kit. If it is 271288, contact Diagnostica Stago for instructions.
The recall is for potential false negative results, not a physical hazard. There is no risk of injury from using the kit itself.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1084-2026 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1084-2026 from Diagnostica Stago. 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.
