Agency classClass IIOur severity:High FDA (Devices)·Z-0990-2013·Announced 2013-04-03

Biomerieux VITEK 2 XL Computer System Recalled for Patient Data Linking Errors

Biomerieux Inc. is recalling VITEK 2 XL computer systems equipped with specific Hewlett-Packard PCs due to a potential risk of linking 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 is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient data) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Biomerieux Inc. is recalling VITEK 2 XL computer systems that are equipped with specific Hewlett-Packard PC models. The VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The recall covers units manufactured from September 2004 to the present, including both new and refurbished units.

The recall is being issued because there is a potential to link an isolate result to the wrong patient and then upload the results to the Laboratory Information System (LIS). This error could result in incorrect patient data being recorded in medical records.

The affected products were distributed worldwide, including in the United States and numerous other countries. The source text does not specify the exact number of units affected in the United States or provide specific instructions for consumers on how to proceed with the recall.

The recalled product

Product: VITEK 2 XL 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 Equipment
Hazard: data-integrity
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

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Same hazard · data integrity