Recall Z-0297-2012 ยท DLJ Calibrators, Drug Specific
Microgenics Corp
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.
| Date | Nov 28, 2011 (initiated Jun 8, 2011) |
| Status | Terminated |
| Reason | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |
| 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 avai |
| Quantity | 809 kits lot 59446762; 651 kits lot 59391741 |
| Distribution | Nationwide Distribution (USA) in the state of ILLINOIS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872644 | INNOFLUOR VANCOMYCIN CALIBRATOR SET Innotron of Oregon, Inc., Jul 21, 1987 |