Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott
FDA device recall Z-1397-2011 · posted 2011-02-23 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- Reason for recall
- Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
- Action taken
- Abbott Molecular sent a Field Advisory Notice letter to all RealTime HIV-1, CT/NG and HBV assay customers on December 20, 2010, informing them that internal testing identified the potential of under filled and over filled enzyme vials which may result in obtaining less than the total number of tests per kit as described in the package insert. The customers were told that specimens that meet acceptance criteria, per the product labeling are not affected by the situation and are considered valid results, and that the issue has no impact on results for those runs that generate valid results. Any questions were directed to Abbott Technical Support at 1-800-553-7042, Option 2.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSK
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-12-20
- Date posted
- 2011-02-23
- Date terminated
- 2012-11-19
- Location
- Des Plaines, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704) | Abbott Molecular, Inc. | 2010-05-28 |