Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tobramycin Calibrators

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Tobramycin Calibratorssee related information
Date Initiated by FirmNovember 11, 2011
Date PostedJanuary 17, 2012
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-0773-2012
Recall Event ID 60503
510(K)NumberK872349 
Product Classification Calibrators, drug specific - Product Code DLJ
ProductTobramycin 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.
Code Information Lots:   59281991, Exp 11-30-11,  59359468, Exp 2-29-12,   59590335, Exp 6-30-12,   59511648, Exp 8-31-12. 
Recalling Firm/
Manufacturer		 Microgenics Corp
46360 Fremont Blvd
Fremont CA 94538
For Additional Information ContactLisa Charter
510-979-5142
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThermoFisher 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 Commerce1366 kits
DistributionWorldwide Distribution -- Nationwide Distribution including the country Europe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DLJ
-
-