FDAOctober 13, 2021device
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
What to do
FDA enforcement status: Ongoing
Brands named
instrumentation laboratoryinstrumentation
UPCs
08426950632887
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. 00055415005.2026-01-20
- FDAGEM Premier 5000; Part No. 00055415008.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407504.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407508.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407511.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407510.2026-01-20
- FDAGEM Premier 5000; Part No. 00055430004.2026-01-20
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