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Cardiac C-Reactive Protein (Latex) High Sensitive
Roche Diagnostics GmbH · Model 08057605190 · UDI-DI 07613336121207
NQD
Prescription
1
510(k) clearances
18
Adverse events
3
Recalls
22
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-26 | Roche Diagnostics Operations, Inc. | Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
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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.