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VITEK 2 Compact computer system when equipped with the… recallZ-0991-2013 · Biomerieux Inc · initiated Feb 18, 2013

Class II Terminated All recalls posted in March 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomerieux Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0991-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 18, 2013
Posted by the FDA
Mar 25, 2013
Recalling firm
Biomerieux Inc
Quantity
For all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed
Product code
LTW
FDA submissions
K050002
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, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.

Product description

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, Cat. 413642; (10) rp5800WES7, Cat. #413862; (11) d530 6-port, Cat. #W0438; (12) d530 6-port (refurbished), Cat. #W0438R; and (13) d530 4-port, Cat. #W0437. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

Code information (models, lots, serial numbers)

Manufactured from September, 2004, to present.

Other devices under the same FDA submission

6 devices cleared under K050002 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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