Category
Diagnostic Devices Recalls
1,863 diagnostic devices recalls on record from CPSC, FDA, and USDA.
1,863 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices92 affectedJun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing ...
Diagnostic Devices5 affectedJun 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector ...
Diagnostic Devices667 affectedJun 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube an...
Diagnostic Devices699 affectedJun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of cl...
Diagnostic Devices35 affectedJun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical...
Diagnostic Devices115 affectedJun 29, 2018
High RiskFDA
Luminex Corporation
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner La...
Diagnostic Devices153 affectedJun 29, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinic...
Diagnostic Devices45 affectedJun 29, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices2 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Diagnostic Devices2 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices0 affectedJun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 (Stitching Patient Support) 709030
Diagnostic Devices0 affectedJun 27, 2018
RecallFDA
Tosoh Bioscience Inc
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte r...
Diagnostic Devices9 affectedJun 5, 2018
High RiskFDA
Qiagen
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Diagnostic Devices287 affectedMay 28, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagn...
Diagnostic Devices6 affectedMay 25, 2018
High RiskFDA
Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Diagnostic Devices0 affectedMay 22, 2018
High RiskFDA
Guangzhou Wondfo Biotech Co., Ltd.
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-C...
Diagnostic Devices60,000 affectedMay 18, 2018
High RiskFDA
Guangzhou Wondfo Biotech Co., Ltd.
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T...
Diagnostic Devices50,000 affectedMay 18, 2018
High RiskFDA
Guangzhou Wondfo Biotech Co., Ltd.
TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube¿ One Step Multi-Drug Oral...
Diagnostic Devices16,000 affectedMay 18, 2018
High RiskFDA
Abbott Laboratories, Inc
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the...
Diagnostic Devices8,037 affectedMay 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antige...
Diagnostic Devices9,586 affectedMay 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Anti...
Diagnostic Devices2,112 affectedMay 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antige...
Diagnostic Devices12,995 affectedMay 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antige...
Diagnostic Devices11,063 affectedMay 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibo...
Diagnostic Devices2,273 affectedMay 16, 2018
High RiskFDA
Polymedco, Inc.,/polymedco Cancer Diagnostic Products, Llc
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the...
Diagnostic Devices272 affectedApr 30, 2018
High RiskFDA
Polymedco, Inc.,/polymedco Cancer Diagnostic Products, Llc
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnosti...
Diagnostic Devices272 affectedApr 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Diagnostic Devices7,543 affectedApr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, ...
Diagnostic Devices20,373 affectedApr 19, 2018
High RiskFDA
Becton Dickinson & Company
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, t...
Diagnostic Devices0 affectedApr 11, 2018