FDADecember 18, 2024device
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
instrumentation laboratoryinstrumentation
UPCs
08426950472483
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGEM Premier 5000; Part No. 00055415010.2026-01-20
- FDAGEM Premier 5000; Part No. 00055415008.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407511.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407508.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407510.2026-01-20
- FDAGEM Premier 5000; Part No. 00055415005.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407504.2026-01-20
- FDAGEM Premier 5000; Part No. 00055430004.2026-01-20
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