Siemens Healthcare Diagnostics, Inc.: 283 recalls on record

Recalls filed with 1 agency: FDA (283).

First recall on record: July 4, 2012. Most recent: August 26, 2026.

Risk classification: Class I: 13 · Class II: 238 · Class III: 32

Most recent recalls

DateAgencyProduct
September 18, 2024FDAAtellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement o…Z-3101-2024
September 18, 2024FDAADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement …Z-3104-2024
September 18, 2024FDAAtellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11…Z-3063-2024
September 18, 2024FDAADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement o…Z-3103-2024
September 18, 2024FDADimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (…Z-3065-2024
September 18, 2024FDAADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN)…Z-3064-2024
July 3, 2024FDASoftware version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Numbe…Z-2214-2024
May 29, 2024FDAIMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyr…Z-1887-2024
May 29, 2024FDAIMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyr…Z-1886-2024
April 24, 2024FDAAtellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and pl…Z-1549-2024
March 27, 2024FDADCA Systems HbA1c Reagent KitZ-1304-2024
March 20, 2024FDAAtellica IM Erythropoietin (EPO) Assay (100 Test)Z-1280-2024
March 20, 2024FDAADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Z-1281-2024
February 14, 2024FDATotal immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryZ-1003-2024
September 6, 2023FDAAtellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative deter…Z-2473-2023
September 6, 2023FDAAtellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative meas…Z-1270-2023
October 26, 2022FDADimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD …Z-0089-2023
June 15, 2022FDAAtellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro …Z-1252-2022
May 11, 2022FDAADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative…Z-1024-2022
May 11, 2022FDAADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quanti…Z-1025-2022
December 8, 2021FDADimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical p…Z-0331-2022
June 23, 2021FDAAtellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11…Z-1870-2021
April 21, 2021FDAADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology a…Z-1405-2021
March 17, 2021FDADimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid …Z-1188-2021
December 30, 2020FDAAtellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnosti…Z-0722-2021

Questions about this company

How many recalls does Siemens Healthcare Diagnostics, Inc. have?
Recalert has 283 U.S. recalls on record for Siemens Healthcare Diagnostics, Inc., published between July 4, 2012 and August 26, 2026.
Which agencies have handled Siemens Healthcare Diagnostics, Inc. recalls?
Siemens Healthcare Diagnostics, Inc. appears as the recalling firm in recalls from: FDA (283).

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