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U.S. Department of Health and Human Services

Class 2 Device Recall Multigent Vancomycin Calibrators

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  Class 2 Device Recall Multigent Vancomycin Calibrators see related information
Date Initiated by Firm June 08, 2011
Date Posted November 28, 2011
Recall Status1 Terminated 3 on February 17, 2012
Recall Number Z-0297-2012
Recall Event ID 60233
510(K)Number K872644  
Product Classification Calibrators, drug specific - Product Code DLJ
Product Multigent Vancomycin Calibrators;
Manufactured by Microgenics Corp, Fremont, CA.
Distributed by: Abbott Diagnostics, Abbott Park, IL


Product Usage:
The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin
Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.
Code Information Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.
Recalling Firm/
Manufacturer
Microgenics Corp
46360 Fremont Blvd
Fremont CA 94538
For Additional Information Contact Lisa Charter
510-979-5000
Manufacturer Reason
for Recall
Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342. Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.
Quantity in Commerce 809 kits lot 59446762; 651 kits lot 59391741
Distribution Nationwide Distribution (USA) in the state of ILLINOIS
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DLJ and Original Applicant = INNOTRON OF OREGON, INC.
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