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Lumipulse BRAHMS PCT Controls
FUJIREBIO INC. · Model 234945 · UDI-DI 04987270234945
1
510(k) clearances
8
Adverse events
2
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2014-04-10 | Siemens Healthcare Diagnostics, Inc | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.