Reported Feb 5, 2025 · Ongoing
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- HemosIL Heparin Calibrators
- Part Number0020300600; in vitro diagnostic
- Lot codes and dates
- Part Number0020300600
- UDI-DI08426950472483
- Lot Numbers
N0128933N0220450N0522479N0724070N1026509N0239584N0531891N0733658N0249207N0442161N0744673****Lot numbers added 4/15/2026**** N0531891N0733658N0249207N0442161N0744673N1147734N020463N0250464N0452277N0553155N0754506
- Amount recalled
- 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026)
Where it was sold
- Nationwide
- GA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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