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PCT AccuLite CLIA Test System - 192 Wells
MONOBIND, INC. · Model 9275-300 · UDI-DI 00816870023458
NTM
Prescription
3
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.