FDA (Devices) recall action 79505
The FDA (Devices) publishes a recall like this one as 24 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 24 pages.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
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.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.
Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.
Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.
Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.
Siemens Healthcare Diagnostics is recalling IMMULITE CA125 assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur DHEA-SO4 kits because the instructions for use incorrectly state the level at which biotin does not interfere.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin interference is not documented in the instructions, potentially affecting test accuracy.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.
Siemens Healthcare Diagnostics is recalling Dimension Vista Cardiac Troponin I reagent cartridges because they are susceptible to interference from biotin, which is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.