United StatesDiagnostica Stago’s Asserachrom HPIA kit (Model/Catalog 00615; Lot 271288; UDI (01)03607450006155(11)240531(17)260531(10)271288(241)00615) intended for qualitative detection in plasma or serum of anti‑heparin–PF4 antibodies by ELISA is being recalled. Lot 271288 may have a defect affecting every well in the impacted strip and can produce negative results.
What's being recalled
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.
Recalling firm: Diagnostica Stago, Inc., Parsippany, NJ, United States.
How to identify it
Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
The hazard
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)