Z-0773-2012

Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538...

Name: Z-0773-2012 Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538...
Creator: Microgenics Corp
Published: 2011-11-11
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2011-11-11 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corp began a recall of Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road... on 2011-11-11. The reason FDA records is "Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0773-2012
Status: Terminated
Initiated: 2011-11-11
Posted: 2012-01-17
Terminated: 2012-05-09
Recalling firm: Microgenics Corporation
Product: 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.
Product code: DLJ Calibrators, Drug Specific
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1366 kits
Distribution: Worldwide Distribution -- Nationwide Distribution including the country Europe.
Product codes and lots: Lots: 59281991, Exp 11-30-11, 59359468, Exp 2-29-12, 59590335, Exp 6-30-12, 59511648, Exp 8-31-12.

Product code DLJ

K872349Class IIInnofluor (Tm) Tobramycin Calibrator SetInnotron of Oregon, Inc. / cleared 1987-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)