Diagnostica Stago, Inc. device recall (Cls II)

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. — Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. — Status: Ongoing