Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Letsgetchecked Inc.
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and prese...
Diagnostic Devices·50 affected·Mar 16, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Diagnostic Devices·952 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All ...
Diagnostic Devices·88 affected·Mar 3, 2022
High RiskFDA
Microbiologics Inc
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria...
Diagnostic Devices·13 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 Al...
Diagnostic Devices·230 affected·Mar 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Diagnostic Devices·374 affected·Mar 3, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnos...
Diagnostic Devices·35 affected·Feb 25, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diag...
Diagnostic Devices·94 affected·Feb 25, 2022
High RiskFDA
Philips North America Llc
DigitalDiagnost C50 1.1
Diagnostic Devices·11 affected·Feb 25, 2022
High RiskFDA
Meridian Bioscience Inc
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog N...
Diagnostic Devices·452 affected·Feb 15, 2022
High RiskFDA
Philips Medical Systems
CombiDiagnost R90 1.1 (709031)
Diagnostic Devices·130 affected·Feb 11, 2022
High RiskFDA
Abbott Laboratories, Inc
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro di...
Diagnostic Devices·306 affected·Feb 3, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. ...
Diagnostic Devices·14,220 affected·Jan 28, 2022
High RiskFDA
Neumodx Molecular Inc
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in in...
Diagnostic Devices·102 affected·Jan 21, 2022
High RiskFDA
Sight Diagnostics Ltd
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image ...
Diagnostic Devices·322 affected·Jan 20, 2022
High RiskFDA
Microgenics Corporation
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMU...
Diagnostic Devices·615 affected·Jan 20, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended fo...
Diagnostic Devices·2,846 affected·Jan 19, 2022
High RiskFDA
Cytocell Ltd.
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Nu...
Diagnostic Devices·19 affected·Jan 18, 2022
CriticalFDA
Lusys Laboratories, Inc.
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Diagnostic Devices·90,849 affected·Jan 13, 2022
High RiskFDA
Konica Minolta Healthcare Americas, Inc.
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for me...
Diagnostic Devices·30 affected·Dec 3, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human s...
Diagnostic Devices·46 affected·Dec 1, 2021
High RiskFDA
Medline Industries, Lp - Northfield
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Diagnostic Devices·100 affected·Dec 1, 2021
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Diagnostic Devices·1,416 affected·Nov 22, 2021
High RiskFDA
Philips North America Llc
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applic...
Diagnostic Devices·5 affected·Nov 19, 2021
CriticalFDA
Philips North America Llc
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Diagnostic Devices·22 affected·Nov 12, 2021
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduc...
Diagnostic Devices·47 affected·Nov 12, 2021
High RiskFDA
Beckman Coulter Inc.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Diagnostic Devices·1,433 affected·Nov 10, 2021
CriticalFDA
Philips North America Llc
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Diagnostic Devices·512 affected·Oct 21, 2021
CriticalFDA
Philips North America Llc
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Diagnostic Devices·243 affected·Oct 21, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedu...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·3 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional proced...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,326 affected·Oct 15, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,407 affected·Oct 15, 2021
High RiskFDA
Biocheck, Inc.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determ...
Diagnostic Devices·314 affected·Oct 14, 2021
High RiskFDA
Sedecal Sa
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Diagnostic Devices·851 affected·Oct 14, 2021
High RiskFDA
Instrumentation Laboratory
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Diagnostic Devices·5,828 affected·Oct 13, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Diagnostic Devices·12 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
Diagnostic Devices·72 affected·Oct 12, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Diagnostic Devices·23 affected·Oct 12, 2021
RecallFDA
Primus Corporation Dba Trinity Biotech
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01...
Diagnostic Devices·340 affected·Oct 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Diagnostic Devices·261 affected·Sep 22, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Diagnostic Devices·149 affected·Sep 22, 2021
High RiskFDA
Philips Ultrasound Inc
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Diagnostic Devices·107 affected·Sep 21, 2021