The Recall Desk

FDA (Devices) recall action 71786

Roche Diagnostics Operations, Inc. recalled 2 products on 2015-09-02

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
2015-09-02
Critical
0
Units
164

Why these products were recalled

Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg

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

1–2 of 2

  • HighFDA (Devices)··2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Distribution
    8 states