Recall Z-2323-2025— Instrumentation Laboratory

Name: FDA recall Z-2323-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-03

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2025-02-03. It names 2 FDA 510(k) clearances: K213464, K980242. Product: HemosIL LMW Heparin Controls; Part Number: 0020300200;. Reason: 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..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2025-02-03
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K213464 — HemosIL Liquid Anti-XaInstrumentation Laboratory CO·cleared 2022-10-04
K980242 — IL TEST HEPARINInstrumentation Laboratory CO·cleared 1998-03-19

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

HemosIL LMW Heparin Controls; Part Number: 0020300200;

Reason for recall

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.

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