Z-0991-2013Class II

VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100...

Name: Z-0991-2013 VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100...
Creator: Biomerieux Inc
Published: 2013-02-18
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-02-18 / Terminated / root cause: software

FDA source

Biomerieux Inc began a recall of 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)... on 2013-02-18. FDA classified it as Class II and gives the reason as "There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0991-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Posted: 2013-03-25
Terminated: 2014-08-14
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Root cause tag: software
FDA 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 in commerce: 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, 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 codes and lots: Manufactured from September, 2004, to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0989-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25
Z-0990-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25
Z-0991-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25

Product code LTW

K050002Class IIVitek 2 CompactbioMerieux, Inc. / cleared 2005-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)