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cobas® 8800 system
Roche Molecular Systems, Inc. · Model 09575146001 · UDI-DI 07613336206362
0
510(k) clearances
190
Adverse events
3
Recalls
15
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-03 | Abbott Laboratories, Inc | Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe |
| 2021-07-12 | Abbott Laboratories, Inc | A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. |
| 2013-05-06 | Ortho-Clinical Diagnostics | There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and |
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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.