The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution te...
FDA Recall #Z-1095-2026 — Class II — December 11, 2025
Product Description
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Reason for Recall
Potential for microbial contamination.
Recalling Firm
Instrumentation Laboratory — Bedford, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7,720 units
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.
Code Information
Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated