Recall Z-0991-2013 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat. #W0449; (6) dc7800 (refurbished), Cat. #W0449R (7) rp5700, Cat. #W0452; (8) rp5700 (refurbished), Cat. #W0452R; (9) rp5800 XPE,
| Date | Mar 25, 2013 (initiated Feb 18, 2013) |
| Status | Terminated |
| Reason | There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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 Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democrati |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050002 | VITEK 2 COMPACT bioMerieux, Inc., Feb 17, 2005 |