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Emit® 2000 Tobramycin Assay
Siemens Healthcare Diagnostics Inc. · Model 10445332 · UDI-DI 00842768023309
1
510(k) clearances
2
Adverse events
2
Recalls
8
Facilities
Description
Emit® 2000 Tobramycin Assay labeled with the Beckman Coulter® name
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-04-05 | Roche Diagnostics Corp. | Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Onli |
| 2007-04-05 | Roche Diagnostics Corp. | Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Onli |
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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.