CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report

Vitek 2 60 computer system when equipped recalled by Biomerieux

Biomerieux is recalling Vitek 2 60 computer system when equipped with the following Hewlett-Packard PC, distributed nationwide in the US. The recall was initiated on 18 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesManufactured from September, 2004, to present.

Quantity recalledFor all 3 computers types: 16,736 originally distributed; 554 refurbished and redistributed

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0989-2013
FDA event ID: 64394
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2013
FDA classified: 25 Mar 2013
Reported: 3 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Mold
Device type: Masks, Gloves & PPE

Timeline

18 Feb 2013	Recall initiated by company
25 Mar 2013	Classified by FDA	+35 days
3 Apr 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Vitek 2 60 computer system when equipped with the following Hewlett-Packard PC recalled?

Yes. Biomerieux recalled Vitek 2 60 computer system when equipped with the following Hewlett-Packard PC on 18 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0989-2013.

Why was it recalled?

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

Which lots are affected?

Manufactured from September, 2004, to present.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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