Category

Diagnostic Devices Recalls

1,863 diagnostic devices recalls on record from CPSC, FDA, and USDA.

1,863 recalls
CriticalFDA
Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system cons...
Diagnostic Devices·2,402 affected·Oct 2, 2023
High RiskFDA
Stanbio Laboratory, Lp
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Diagnostic Devices·2,351 affected·Oct 2, 2023
High RiskFDA
Sentinel Ch Spa
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Diagnostic Devices·4,394 affected·Sep 29, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·13 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Diagnostic Devices·46 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·366 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·1 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·2 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Diagnostic Devices·101 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·143 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·33 affected·Sep 21, 2023
High RiskFDA
Philips North America Llc
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Diagnostic Devices·40 affected·Sep 21, 2023
High RiskFDA
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary w...
Diagnostic Devices·11,442 affected·Sep 19, 2023
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Diagnostic Devices·36 affected·Sep 12, 2023
High RiskFDA
Qiagen Gmbh
therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic m...
Diagnostic Devices·0 affected·Aug 22, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Diagnostic Devices·19,115 affected·Aug 15, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Diagnostic Devices·4,966 affected·Aug 8, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determ...
Diagnostic Devices·3,067 affected·Jul 25, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4,...
Diagnostic Devices·166 affected·Jul 19, 2023
High RiskFDA
Wom World Of Medicine Ag
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to mon...
Diagnostic Devices·1,287 affected·Jul 17, 2023
High RiskFDA
Instrumentation Laboratory
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrino...
Diagnostic Devices·2,068 affected·Jul 13, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human ...
Diagnostic Devices·19,544 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (l...
Diagnostic Devices·18,524 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (l...
Diagnostic Devices·50,148 affected·Jul 10, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lit...
Diagnostic Devices·6,733 affected·Jul 10, 2023
CriticalFDA
Siemens Medical Solutions Usa, Inc
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 1084...
Diagnostic Devices·10 affected·Jun 19, 2023
CriticalFDA
Siemens Medical Solutions Usa, Inc
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number...
Diagnostic Devices·7 affected·Jun 19, 2023
High RiskFDA
Randox Laboratories Ltd.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Diagnostic Devices·37 affected·Jun 13, 2023
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Diagnostic Devices·4,013 affected·Jun 5, 2023
High RiskFDA
Remel, Inc
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For ...
Diagnostic Devices·1,296 affected·May 31, 2023
High RiskFDA
Phadia Ab
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Diagnostic Devices·124,928 affected·May 24, 2023
High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
Diagnostic Devices·122,500 affected·May 22, 2023
RecallFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration rang...
Diagnostic Devices·2 affected·May 18, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of a...
Diagnostic Devices·1 affected·May 4, 2023
RecallFDA
Randox Laboratories Ltd.
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducib...
Diagnostic Devices·30 affected·May 4, 2023
RecallFDA
Abbott Ireland Limited
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Diagnostic Devices·110 affected·Apr 24, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mm...
Diagnostic Devices·23,751 affected·Apr 17, 2023
RecallFDA
Mechatronics Usa
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precis...
Diagnostic Devices·9,306 affected·Apr 14, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Version...
Diagnostic Devices·132 affected·Apr 14, 2023
RecallFDA
Mechatronics Usa
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of S...
Diagnostic Devices·10,752 affected·Apr 14, 2023
High RiskFDA
Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Diagnostic Devices·355 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700...
Diagnostic Devices·1,068 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Diagnostic Devices·306 affected·Apr 5, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibratin...
Diagnostic Devices·6,546 affected·Apr 5, 2023
High RiskFDA
Immundiagnostik, Inc
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 S...
Diagnostic Devices·88 affected·Mar 27, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material Number: 10...
Diagnostic Devices·4 affected·Mar 21, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro d...
Diagnostic Devices·34,746 affected·Mar 16, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol...
Diagnostic Devices·18,961 affected·Mar 16, 2023