Instrumentation Laboratory recalls HemosIL Heparin Calibrators (Part 0020300600) due to potential lower quality control results. Affected units include specific lot numbers listed in the recall notice.
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.
Instrumentation Laboratory is recalling HemosIL Heparin Calibrators with part number 0020300600 because they may produce QC results that are too low. This could lead to inaccurate blood tests if used in medical settings.
The calibrators may indicate lower quality control results than expected, potentially leading to inaccurate blood test results. This could affect the reliability of diagnostic tests if the device is used in medical settings.
Healthcare professionals using these calibrators for blood tests are most at risk. Patients relying on accurate test results from these devices may be affected.
Check for part number 0020300600 on the device. Affected units include specific lot numbers listed in the recall notice (N0128933, N0220450, etc.).
Look for lot numbers on the device, such as N0128933, N0220450, or others listed in the recall notice.
The part number is 0020300600.
Affected lot numbers include N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673, and others listed in the recall notice.
The recall does not specify a stop-use action, so you do not need to stop using them immediately. However, check the lot number to see if your device is affected.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1020-2025 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1020-2025 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.
