Z-0297-2012

Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott...

Name: Z-0297-2012 Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott...
Creator: Microgenics Corp
Published: 2011-06-08
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2011-06-08 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corp began a recall of Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The... on 2011-06-08. The reason FDA records is "Complaint from the sole distributor that the third party control material is recovering high, and outside 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-0297-2012
Status: Terminated
Initiated: 2011-06-08
Posted: 2011-11-28
Terminated: 2012-02-17
Recalling firm: Microgenics Corporation
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.
Product code: DLJ Calibrators, Drug Specific
Reason for recall: Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.

Product code DLJ

K872644Class IIInnofluor Vancomycin 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)