Recall Z-1084-2026— Diagnostica Stago, Inc.

Name: FDA recall Z-1084-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-15

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2025-12-15. It names one FDA 510(k) clearance: K003767. Product: 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..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-15
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K003767 — ASSERACHROM HPIA TEST KITDiagnostica Stago, Inc.·cleared 2001-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.