The Recall Desk

FDA (Devices) recall action 85602

Siemens Healthcare Diagnostics, Inc. recalled 6 products on 2020-06-17

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
2020-06-17
Critical
0
Units
34,610

Why these products were recalled

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient 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

  • ModerateFDA (Devices)··2020-06-17

    Siemens ADVIA Chemistry Fructosamine Reagent Recalled for Potential Interference

    Siemens is recalling ADVIA Chemistry Fructosamine Reagent because acetaminophen metabolites may interfere with test results, potentially affecting diabetic patient monitoring.

    Product
    ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients…
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2020-06-17

    Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2020-06-17

    Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Distribution
    42 states
  • ModerateFDA (Devices)··2020-06-17

    Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding…
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Distribution
    42 states
  • HighFDA (Devices)··2020-06-17

    Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.

    Product
    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Distribution
    42 states