Diagnostica Stago issued a recall for 438 Asserachrom HPIA kits on December 15, 2025. The kits, used to detect PF4 antibodies, may produce false negative results. The affected lot is 271288, distributed worldwide including multiple U.S. states.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The Asserachrom HPIA kit is used for the qualitative detection of anti-heparin-platelet factor 4 antibodies in plasma or serum. It is primarily utilized in diagnosing heparin-induced thrombocytopenia, a serious condition that can occur after heparin treatment.
The defect in the Asserachrom HPIA kit affects every well in the impacted strip, leading to potentially false negative results. This can result in undiagnosed cases of heparin-induced thrombocytopenia, posing severe health risks.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients relying on accurate diagnosis of heparin-induced thrombocytopenia. The potential for false negatives raises critical safety concerns.
The lot number can typically be found on the packaging or the kit itself, often near the barcode or product details.
Expect processing for refunds or replacements to take approximately 4-6 weeks.
Keep copies of any correspondence regarding the recall, as well as receipts and product details for your records.
The Asserachrom HPIA kit, Model/Catalog Number 00615, is designed for the qualitative detection of anti-heparin-platelet factor 4 antibodies in plasma or serum. It was distributed widely, including to states such as California, New York, and Florida, as well as internationally.
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