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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 Devices·92 affected·Jun 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 Devices·5 affected·Jun 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 Devices·667 affected·Jun 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 Devices·699 affected·Jun 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 Devices·35 affected·Jun 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 Devices·115 affected·Jun 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 Devices·153 affected·Jun 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 Devices·45 affected·Jun 29, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices·2 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Diagnostic Devices·2 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 (Stitching Patient Support) 709030
Diagnostic Devices·0 affected·Jun 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 Devices·9 affected·Jun 5, 2018
High RiskFDA
Qiagen
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
Diagnostic Devices·287 affected·May 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 Devices·6 affected·May 25, 2018
High RiskFDA
Randox Laboratories Ltd.
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Diagnostic Devices·0 affected·May 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 Devices·60,000 affected·May 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 Devices·50,000 affected·May 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 Devices·16,000 affected·May 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 Devices·8,037 affected·May 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 Devices·9,586 affected·May 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 Devices·2,112 affected·May 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 Devices·12,995 affected·May 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 Devices·11,063 affected·May 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 Devices·2,273 affected·May 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 Devices·272 affected·Apr 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 Devices·272 affected·Apr 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 Devices·7,543 affected·Apr 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 Devices·20,373 affected·Apr 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 Devices·0 affected·Apr 11, 2018