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.
FDA Recall Z-0297-2012 · Posted 2011-11-28
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Recalling FirmMicrogenics Corp
Recall StatusTerminated
Product CodeDLJ
Date Initiated2011-06-08
Date Terminated2012-02-17
Product Quantity809 kits lot 59446762; 651 kits lot 59391741
Reason for Recall
Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution (USA) in the state of ILLINOIS
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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