Instrumentation Laboratory

4 FDA enforcement actions

4 Total Recalls

0 Class I

3 Class II

1 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class II: Risk 12/11/2025 device

Potential for microbial contamination.
Class III: Low Risk 11/18/2025 device

Recalled lots were manufactured with double the amount of preservative concentration.
Class II: Risk 02/03/2025 device

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 device

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.

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.