Agency classClass IIOur severity:High FDA (Devices)·Z-0989-2013·Announced 2013-04-03

Biomerieux VITEK 2 60 Computer System Recalled for Data Linking Error

Biomerieux Inc is recalling VITEK 2 60 computer systems due to a potential error that could link test results to the wrong patient.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential clinical data errors.

Plain-English summary

Biomerieux Inc is recalling VITEK 2 60 computer systems equipped with specific Hewlett-Packard PC models. The recall involves 16,736 originally distributed units and 554 refurbished units that were redistributed. These systems are automated devices designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

The recall is being issued because there is a potential for the system to link an isolate result to the wrong patient and then upload those incorrect results to the Laboratory Information System (LIS). This data integrity issue could lead to clinical decisions being based on mismatched patient data.

The affected products were manufactured from September 2004 to the present and were distributed worldwide, including the United States and numerous other countries. Healthcare facilities and laboratories using these systems should contact Biomerieux Inc for instructions on how to address the potential data linking error.

The recalled product

Product: 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…
Manufacturer: Biomerieux Inc
Category: Medical Device — Laboratory Diagnostic Equipment
Hazard: data-integrity-error
mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Manufactured from September
2004
to present.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Biomerieux Inc

See all →

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Same hazard · data integrity error