United StatesInstrumentation Laboratory is recalling the product used for evaluation of the intrinsic coagulation pathway, APTT substitution testing, and monitoring of heparin therapy, identified as Part Number 0020006800, UDI‑DI 08426950078920, Lot N1136730, expiration date 12/31/2025. The recall was issued because of a potential for microbial contamination; 7,720 units were distributed worldwide, including listed U.S. states and countries.
What's being recalled
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Recalling firm: Instrumentation Laboratory, Bedford, MA, United States.
How to identify it
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
The hazard
Potential for microbial contamination.
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 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.
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)