Instrumentation Laboratory: The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Hazard

Potential for microbial contamination.

Details from the source

Reason for recall: Potential for microbial contamination. Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo. Quantity: 7,720 units Lot/code info: Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.

UPC codes

08426950078920

Source

Official record: FDA (Device enforcement) ↗

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