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VITROS
ORTHO CLINICAL DIAGNOSTICS · Model 6195575 · UDI-DI 10758750033294
PMT
Prescription
5
510(k) clearances
13
Adverse events
1
Recalls
21
Facilities
Description
VITROS Immunodiagnostic Products BRAHMS PCT Calibrator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-22 | Roche Diagnostics Corporation | Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers. |
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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.