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Gentamicin
Roche Diagnostics GmbH · Model 20737844322 · UDI-DI 04015630915712
LCQ
Prescription
1
510(k) clearances
7
Adverse events
3
Recalls
4
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-11-11 | ConvaTec, Inc | The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer. |
| 2007-10-26 | Abbott Diagnostic International, Ltd. | Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: |
| 2007-10-26 | Abbott Diagnostic International, Ltd. | Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: |
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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.