Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is Recalled by Diagnostica Stago, Inc. Due to Potential for defect for Asserachrom HPIA lot 271288,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Quantity: 438 units
Why Was This Recalled?
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report