The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress…
Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Siemens Healthcare Diagnostics, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.