VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W04
FDA device recall Z-0991-2013 · posted 2013-03-25 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
- Action taken
- bioMerieux sent an "URGENT PRODUCT CORRECTION NOTICE" dated February 20, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Emails were issued by the recalling firm on 2/18/2013 and 2/19/2013 to their subsidiaries and to distributors. Letters began issuing to customers via e-mail on 2/20/2013. Contact bioMerieux Clinical Customer Service at (800) 682-2666 for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LTW
- Quantity affected
- For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina
- Date initiated
- 2013-02-18
- Date posted
- 2013-03-25
- Date terminated
- 2014-08-14
- Location
- Hazelwood, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITEK 2 COMPACT (K050002) | bioMerieux, Inc. | 2005-02-17 |