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, 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.
The affected lot 271288 may produce false negative results in all wells of the impacted strips. This defect poses a significant risk as it can lead to undiagnosed heparin-induced thrombocytopenia.
No specific incidents have been reported. However, the potential for false negatives raises serious concerns for patient safety.
Stop using the Asserachrom HPIA kit immediately. Follow the recall instructions provided by Diagnostica Stago, Inc. Contact your healthcare provider for further instructions.
For more information, contact Diagnostica Stago, Inc. via email. Detailed recall information is available at the FDA website.
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