Siemens Healthcare Diagnostics, Inc.: Medical Device Recalls in 2022

According to to data from the FDA, there were 29 medical device recalls made by Siemens Healthcare Diagnostics, Inc. in 2022. See the details of the recalls below.

You can see similar recalls for other firms.

• Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
• IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
• Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
• Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
• Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
• Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
• Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
• IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
• Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
• IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
• Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
• ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
• Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
• Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
• Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
• Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
• Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
• Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
• Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
• Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).
• ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
• IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
• IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
• Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
• ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
• IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
• 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
• 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