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.
FDA Recall Z-0773-2012 · Posted 2012-01-17
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Recalling FirmMicrogenics Corp
Recall StatusTerminated
Product CodeDLJ
Date Initiated2011-11-11
Date Terminated2012-05-09
Product Quantity1366 kits
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- Nationwide Distribution including the country Europe.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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