Recall Z-0773-2012 ยท DLJ Calibrators, Drug Specific
Microgenics Corp
Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections.
| Date | Jan 17, 2012 (initiated Nov 11, 2011) |
| Status | Terminated |
| Reason | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1366 kits |
| Distribution | Worldwide Distribution -- Nationwide Distribution including the country Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872349 | INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET Innotron of Oregon, Inc., Jul 21, 1987 |