Instrumentation Laboratory: Device Recall

Recall #Z-0938-2026 · 11/18/2025

Class III: Low Risk

Recall Details

Recall Number: Z-0938-2026
Classification: Class III
Product Type: Device
Recalling Firm: Instrumentation Laboratory
Status: Ongoing
Date Initiated: 11/18/2025
Location: Bedford, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,506 units

Reason for Recall

Recalled lots were manufactured with double the amount of preservative concentration.

Product Description

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Distribution Pattern

Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.

Other Recalls by Instrumentation Laboratory

Class II: Risk 12/11/2025

Potential for microbial contamination.
Class II: Risk 02/03/2025

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Class II: Risk 12/18/2024

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

View all recalls by Instrumentation Laboratory →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.