FDA recall Z-1084-2026

Diagnostica Stago, Inc. · Class II · device

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 for recall

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

Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI, IA, MA, MI, NJ, NV, NY, OH, TN, WI and the countries of Belgium, Canada, Denmark, Algeria, Spain, Finland, France, Great Britain, Italy, Lebanon, Saudi Arabia, Uganda.

Key facts

Status
Ongoing
Initiation date
2025-12-15
Report date
2026-01-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1084-2026