Instrumentation Laboratory recalls The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring…

Recall date

December 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1095-2026

FDA classification

Class II

Brand / firm

Instrumentation Laboratory

Sold / distributed

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.

Why it was recalled

Potential for microbial contamination.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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