Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abb
FDA device recall Z-0297-2012 · posted 2011-11-28 · Terminated
Recall details
- Recalling firm
- Microgenics Corp
- Reason for recall
- Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
- Action taken
- 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
- Status
- Terminated
- Product code
- DLJ
- Quantity affected
- 809 kits lot 59446762; 651 kits lot 59391741
- Distribution
- Nationwide Distribution (USA) in the state of ILLINOIS
- Date initiated
- 2011-06-08
- Date posted
- 2011-11-28
- Date terminated
- 2012-02-17
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOFLUOR VANCOMYCIN CALIBRATOR SET (K872644) | Innotron of Oregon, Inc. | 1987-07-21 |