Diagnostica Stago, Inc.: 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

Hazard

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

Details from the source

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. Quantity: 438 units Lot/code info: Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.

UPC codes

03607450006155

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.