The Recall Desk

FDA (Devices) recall action 65247

Ortho-Clinical Diagnostics recalled 2 products on 2013-07-03

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
2013-07-03
Critical
0
Units
—

Why these products were recalled

While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.

While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.

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

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2013-07-03

    Ortho-Clinical VITROS Potassium Slides Recalled for Unintentional Surfactant Addition

    Ortho-Clinical Diagnostics is recalling VITROS Potassium Slides because a surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/9
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2013-07-03

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because an excess amount of surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/
    Category
    Distribution
    1 state