Siemens Healthcare Diagnostics, Inc.
444 recalls on record · Latest: Nov 19, 2025
FDA Devices Moderate Dec 24, 2014
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the…
FDA Devices Moderate Dec 3, 2014
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is a…
FDA Devices Low Nov 26, 2014
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog N…
FDA Devices Critical Nov 19, 2014
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in de…
FDA Devices Critical Nov 19, 2014
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the speci…
FDA Devices Low Nov 19, 2014
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems …
FDA Devices Moderate Nov 5, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 67…
FDA Devices Moderate Nov 5, 2014
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: …
FDA Devices Moderate Nov 5, 2014
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic tes…
FDA Devices Moderate Oct 8, 2014
Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol…
FDA Devices Moderate Sep 24, 2014
Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system d…
FDA Devices Moderate Sep 3, 2014
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Ser…
FDA Devices Moderate Jul 30, 2014
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 50…
FDA Devices Moderate Jul 9, 2014
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro …
FDA Devices Moderate Jul 9, 2014
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
FDA Devices Moderate Jul 2, 2014
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laborator…
FDA Devices Moderate Jul 2, 2014
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 …
FDA Devices Moderate Jul 2, 2014
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibrat…
FDA Devices Moderate Jun 18, 2014
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Di…
FDA Devices Moderate Jun 4, 2014
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determinat…
FDA Devices Moderate Jun 4, 2014
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determinatio…
FDA Devices Moderate Jun 4, 2014
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro dia…
FDA Devices Moderate Jun 4, 2014
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
FDA Devices Moderate Jun 4, 2014
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diag…
FDA Devices Moderate May 28, 2014
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in h…
FDA Devices Low May 14, 2014
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
FDA Devices Moderate May 14, 2014
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (R…
FDA Devices Moderate Feb 12, 2014
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenyt…
FDA Devices Moderate Feb 12, 2014
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of pheny…
FDA Devices Moderate Feb 5, 2014
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined M…
FDA Devices Moderate Jan 29, 2014
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human …
FDA Devices Moderate Jan 15, 2014
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1…
FDA Devices Moderate Jan 1, 2014
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneo…
FDA Devices Moderate Dec 25, 2013
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus i…
FDA Devices Moderate Dec 25, 2013
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of tot…
FDA Devices Moderate Dec 11, 2013
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic d…
FDA Devices Moderate Dec 11, 2013
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLA…
FDA Devices Low Nov 13, 2013
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the AD…
FDA Devices Moderate Nov 6, 2013
Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diag…
FDA Devices Moderate Nov 6, 2013
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood ga…
FDA Devices Moderate Nov 6, 2013
Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional us…
FDA Devices Moderate Nov 6, 2013
Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro di…
FDA Devices Moderate Oct 23, 2013
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein me…
FDA Devices Critical Sep 18, 2013
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For …
FDA Devices Critical Sep 18, 2013
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For us…
FDA Devices Critical Sep 18, 2013
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - F…
FDA Devices Critical Sep 18, 2013
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) -…
FDA Devices Critical Sep 18, 2013
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids p…
FDA Devices Critical Sep 18, 2013
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (…
FDA Devices Critical Sep 18, 2013