Recall Z-0991-2013— Biomerieux Inc

Name: FDA recall Z-0991-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-18

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2013-02-18, terminated 2014-08-14. It names one FDA 510(k) clearance: K050002. 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.. Reason: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Terminated: 2014-08-14
Firm location: Hazelwood, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K050002 — VITEK 2 COMPACTbioMerieux, Inc.·cleared 2005-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.