Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbot
FDA device recall Z-0773-2012 · posted 2012-01-17 · Terminated
Recall details
- Recalling firm
- Microgenics Corp
- Reason for recall
- Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range.
- Action taken
- ThermoFisher Scientific sent a product removal letter dated November 11, 2011. Letters were sent to the sole distributor of the product. The letter identified the product the problem and the action needed to be taken by the customer. If you are using or have inventory of the affected lot numbers immediately discontinue use and destroy any remaining affected lot numbers per your local waste ordinances. If you have any further questions regarding this information please call 1-877-4Abbott. Customers outside the US should contact their local customer service.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DLJ
- Quantity affected
- 1366 kits
- Distribution
- Worldwide Distribution -- Nationwide Distribution including the country Europe.
- Date initiated
- 2011-11-11
- Date posted
- 2012-01-17
- Date terminated
- 2012-05-09
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET (K872349) | Innotron of Oregon, Inc. | 1987-07-21 |