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VITROS
ORTHO CLINICAL DIAGNOSTICS · Model 6801390 · UDI-DI 10758750001149
MJX
Prescription
7
510(k) clearances
2
Adverse events
1
Recalls
14
Facilities
Description
VITROS Immunodiagnostic Products HBsAg Controls
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-22 | Ortho-Clinical Diagnostics | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Contr |
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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.