The Recall Desk

FDA (Devices) recall action 69292

Siemens Healthcare Diagnostics, Inc recalled 2 products on 2014-10-29

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
2014-10-29
Critical
0
Units
5,434

Why these products were recalled

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

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.

1–2 of 2

  • HighFDA (Devices)··2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the cor
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-10-29

    Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision

    Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.

    Product
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of
    Category
    Distribution
    0 states