The Recall Desk

FDA (Devices) recall action 68286

Ortho-Clinical Diagnostics recalled 2 products on 2014-06-25

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-06-25
Critical
0
Units
—

Why these products were recalled

Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

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

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products FS Calibrator 1

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products FS Calibrator 1 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2014-06-25

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 17

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 17 because calibrator values were assigned using a reference method that was not fully validated.

    Product
    VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry…
    Category
    Distribution
    1 state