The Recall Desk

FDA (Devices) recall action 72643

bioMerieux, Inc. recalled 7 products on 2015-12-23

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2015-12-23
Critical
0
Units
4,382

Why these products were recalled

MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2015-12-23

    bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

    bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA Software Recall for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records.

    Product
    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error

    bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error

    bioMerieux, Inc. is recalling MYLA Clinic Patch 3.2.0 CD software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2015-12-23

    bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Distribution
    42 states