Diagnostica Stago, Inc. has recalled 438 units of the Asserachrom HPIA kit (Lot 271288) due to a defect that can affect every well in a test strip. This defect may cause the laboratory test to produce false negative results for anti-heparin-platelet factor 4 (PF4) antibodies. These kits are used in clinical laboratories to help diagnose type II heparin-induced thrombocytopenia (HIT type II), a serious condition related to heparin treatment.
A false negative result could lead a healthcare provider to miss a diagnosis of HIT type II, a condition where a patient develops life-threatening blood clots in response to the blood thinner heparin. Failure to diagnose this condition can result in serious complications, including stroke, pulmonary embolism, or limb loss.
Intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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