The Recall Desk

FDA (Devices) recall action 67953

Siemens Healthcare Diagnostics, Inc recalled 7 products on 2014-06-04

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2014-06-04
Critical
0
Units
273,253

Why these products were recalled

Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

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.

1–7 of 7

  • ModerateFDA (Devices)··2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference

    Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-06-04

    Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.

    Product
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-04

    Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference

    Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-04

    Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference

    Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-04

    Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Distribution
    0 states