Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Diagnostic Devices·156 affected·Apr 23, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to T...
Diagnostic Devices·22,550 affected·Apr 21, 2021
High RiskFDA
Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Diagnostic Devices·296 affected·Apr 16, 2021
CriticalFDA
Innova Medical Group, Inc.
COVID-19 Self-Test Kit *** INNOVA *** 3T
Diagnostic Devices·402 affected·Apr 9, 2021
CriticalFDA
Innova Medical Group, Inc.
For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
Diagnostic Devices·1,945 affected·Apr 9, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Diagnostic Devices·10 affected·Apr 7, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures i...
Diagnostic Devices·3,320 affected·Mar 30, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Cata...
Diagnostic Devices·143,823 affected·Mar 25, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a...
Diagnostic Devices·133 affected·Mar 19, 2021
High RiskFDA
Cytocell Ltd.
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Diagnostic Devices·89 affected·Mar 19, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behr...
Diagnostic Devices·1,547 affected·Mar 2, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedur...
Diagnostic Devices·29 affected·Feb 26, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination wi...
Diagnostic Devices·12,177 affected·Feb 12, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen...
Diagnostic Devices·2,782 affected·Feb 12, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Diagnostic Devices·390 affected·Feb 8, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequ...
Diagnostic Devices·1,172 affected·Feb 4, 2021
High RiskFDA
Sky Medical Supplies And Equipments Llc
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Med...
Diagnostic Devices·10,000 affected·Jan 19, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li...
Diagnostic Devices·1,214 affected·Jan 6, 2021
RecallFDA
Biomeme, Inc.
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infe...
Diagnostic Devices·147 affected·Jan 5, 2021
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi ...
Diagnostic Devices·12,080 affected·Dec 24, 2020
High RiskFDA
Tenderneeds Fertility Llc
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Diagnostic Devices·0 affected·Dec 23, 2020
High RiskFDA
Nihon Kohden America Inc
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 0493192110...
Diagnostic Devices·189 affected·Dec 21, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for ...
Diagnostic Devices·41 affected·Dec 18, 2020
High RiskFDA
Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EP...
Diagnostic Devices·607 affected·Dec 16, 2020
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/tr...
Diagnostic Devices·113 affected·Dec 10, 2020
High RiskFDA
Philips Home Healthcare Solution
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Diagnostic Devices·91 affected·Dec 8, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product ...
Diagnostic Devices·1,095 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product U...
Diagnostic Devices·2,405 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product ...
Diagnostic Devices·1,588 affected·Dec 2, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·9,768 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·228 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·8,362 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·2,807 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·228 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·611 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers a...
Diagnostic Devices·902 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,527 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,152 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·1,780 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·4,408 affected·Nov 24, 2020
CriticalFDA
Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended...
Diagnostic Devices·631 affected·Nov 24, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma...
Diagnostic Devices·731 affected·Nov 23, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-gl...
Diagnostic Devices·397 affected·Nov 23, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitat...
Diagnostic Devices·40 affected·Nov 20, 2020
High RiskFDA
Roche Molecular Systems, Inc.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucle...
Diagnostic Devices·597 affected·Nov 19, 2020
High RiskFDA
Philips Ultrasound Inc
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Af...
Diagnostic Devices·57,430 affected·Oct 27, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis ...
Diagnostic Devices·46 affected·Oct 16, 2020
High RiskFDA
Olympus Corporation Of The Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a d...
Diagnostic Devices·3,145 affected·Oct 16, 2020