Instrumentation Laboratory: Device Recall

Recall Details

Recall Number

Z-1095-2026

Classification

Class II

Product Type

Device

Recalling Firm

Instrumentation Laboratory

Status

Ongoing

Date Initiated

12/11/2025

Location

Bedford, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

7,720 units

Reason for Recall

Potential for microbial contamination.

Product Description

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

Distribution Pattern

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.

Other Recalls by Instrumentation Laboratory

• Class III: Low Risk 11/18/2025
  Recalled lots were manufactured with double the amount of preservative concentration.
• 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 →