Biomerieux VITEK 2 Compact Computer System Recall for Patient Data Error
Biomerieux Inc. is recalling VITEK 2 Compact computer systems because a software issue 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 patient data errors.
Plain-English summary
Biomerieux Inc. is recalling VITEK 2 Compact computer systems equipped with specific Hewlett-Packard PC models. The recall covers 16,736 originally distributed units and 554 refurbished units. The affected systems are used for the identification and antimicrobial susceptibility testing of bacteria and yeast.
The recall is due to a potential software error that could link an isolate result to the wrong patient and upload those results to the Laboratory Information System (LIS). This error could lead to incorrect patient records.
The affected products were distributed worldwide, including in the United States and numerous other countries. The units were manufactured from September 2004 to the present. Users should contact Biomerieux Inc. for further instructions on how to address this issue.
The recalled product
- 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.…
- Manufacturer
- Biomerieux Inc
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.
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