Instrumentation Laboratory recalls HemosIL LMW Heparin Controls (Part 0020300200) due to inconsistent quality control results that may cause patient testing delays. Affected units include specific lot numbers.
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.
Instrumentation Laboratory is recalling HemosIL LMW Heparin Controls with part number 0020300200 because some tests showed lower quality results than expected. This could delay patient blood tests if the quality control fails.
The controls may produce test results that are too low, causing quality control checks to fail. When this happens, patient blood tests might be delayed because the system won't accept the results.
Patients using HemosIL LMW Heparin Controls for blood tests may be affected if the quality control fails. Laboratory staff and healthcare providers who use these controls are most at risk.
Check for part number 0020300200 on the product label. The affected units include specific lot numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397.
Look for part number 0020300200 on the HemosIL LMW Heparin Controls label.
The recall is due to inconsistent quality control results that may cause patient testing delays.
Affected lot numbers include N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, and N1147397.
No action is required beyond checking the product label for the part number and lot numbers. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-2323-2025 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-2323-2025 from Instrumentation Laboratory. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
