FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0773-2012
- Recalling firm
- Microgenics Corp
- 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.
- Status
- Terminated
- Initiated
- 2011-11-11
- Posted
- 2012-01-17
- Terminated
- 2012-05-09
- 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.
- Lot, serial or model codes
- Lots: 59281991, Exp 11-30-11, 59359468, Exp 2-29-12, 59590335, Exp 6-30-12, 59511648, Exp 8-31-12.
- 510(k) numbers
- ["K872349"]
- PMA numbers
- not on file
- Product code
- DLJ
- Firm FEI
- 3010939897
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28