Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VITEK 2 60 computer system when equipped with the following Recalled by Biomerieux Inc Due to There is a potential to link an isolate...

Date: February 18, 2013
Company: Biomerieux Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biomerieux Inc directly.

Affected Products

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.

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

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biomerieux Inc

Biomerieux Inc has 368 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report