The Recall Desk

FDA (Devices) recall action 76992

Siemens Healthcare Diagnostics, Inc recalled 2 products on 2017-05-24

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
2017-05-24
Critical
0
Units
—

Why these products were recalled

Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.

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

1–2 of 2

  • ModerateFDA (Devices)··2017-05-24

    Siemens Recalls Insulin Calibrators Due to Measurement Deviation

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Insulin Calibrators because they measure approximately 40% higher than the WHO standard.

    Product
    ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-05-24

    Siemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.

    Product
    ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
    Category
    Distribution
    0 states