FDAFebruary 3, 2023device
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
What to do
FDA enforcement status: Ongoing
Brands named
instrumentation laboratoryinstrumentation
UPCs
08426950453017
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 →