FDADecember 11, 2025device
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for microbial contamination.
What to do
FDA enforcement status: Ongoing
Brands named
instrumentation laboratoryinstrumentation
UPCs
08426950078920
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. 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. 00055407511.2026-01-20
- FDAGEM Premier 5000 PAK; Part No. 00055407504.2026-01-20
- FDAGEM Premier 5000; Part No. 00055430004.2026-01-20
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →