The Recall Desk

FDA (Devices) recall action 72979

Ortho-Clinical Diagnostics recalled 5 products on 2016-03-16

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2016-03-16
Critical
0
Units
—

Why these products were recalled

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

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

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2016-03-16

    Ortho-Clinical VITROS 350 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to increased error codes when using specific calibrators.

    Product
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodo
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Error Codes

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because they may generate specific error codes when used with a recalled Calibrator Kit 9 lot.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of cli
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to increased error codes when using a specific calibrator kit.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-03-16

    Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry Sy
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-03-16

    Ortho-Clinical VITROS 250 Chemistry Systems Recalled for Condition Code Errors

    Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems due to increased U90-382 or 6LU condition codes generated when using Calibrator Kit 9, Lot 954.

    Product
    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs disc
    Category
    Distribution
    1 state