The Recall Desk

FDA (Devices) recall action 64394

Biomerieux Inc recalled 3 products on 2013-04-03

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2013-04-03
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-04-03

    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.

    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. #W
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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 (refurbis
    Category
    Distribution
    0 states