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.
What this means for you
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 (refurbis
- 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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