The Recall Desk

FDA (Devices) recall action 91522

Siemens Healthcare Diagnostics, Inc. recalled 6 products on 2023-03-01

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2023-03-01
Critical
0
Units
47,657

Why these products were recalled

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

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

1–6 of 6

  • HighFDA (Devices)··2023-03-01

    ADVIA Centaur Folate 500 test kits recalled for inaccurate measurement results

    Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate results.

    Product
    ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2023-03-01

    Siemens Atellica IM Folate 140 test kit recalled for measurement bias

    Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.

    Product
    Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2023-03-01

    Atellica IM Folate test kit recalled for measurement bias issues

    Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.

    Product
    Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2023-03-01

    Diagnostic folate test kits recalled for negative measurement bias

    Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low folate results.

    Product
    ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2023-03-01

    Siemens Atellica IM Folate 700 test kit recalled for measurement bias

    Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.

    Product
    Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2023-03-01

    Folate test kits recalled for calibration error causing inaccurate results

    Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.

    Product
    ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
    Category
    Distribution
    5 states