The Recall Desk

FDA (Devices) recall action 90387

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2022-07-13

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
2022-07-13
Critical
0
Units
76

Why these products were recalled

Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

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)··2022-07-13

    Siemens Dimension LTNI Cardiac Troponin Test Positive Bias Recall

    Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.

    Product
    Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2022-07-13

    Cardiac Troponin Diagnostic Test Recalled for Positive Bias in Plasma Samples

    Siemens Dimension CTNI cardiac troponin test is recalled for positive bias (falsely elevated readings) in Lithium Heparin plasma samples, which may lead to misdiagnosis of myocardial infarction.

    Product
    Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
    Category
    Distribution
    14 states