Recall Z-1095-2026— Instrumentation Laboratory

Name: FDA recall Z-1095-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-11

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2025-12-11. It names one FDA 510(k) clearance: K060688. Product: The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.. Reason: Potential for microbial contamination..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2025-12-11
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060688 — HEMOSIL SYNTHASILInstrumentation Laboratory CO·cleared 2006-04-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.