Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Med-hot Thermal Imaging, Inc.
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagn...
Diagnostic Devices·12 affected·Jan 14, 2017
RecallFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calib...
Diagnostic Devices·160 affected·Jan 5, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro ...
Diagnostic Devices·11,963 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic...
Diagnostic Devices·9,076 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic us...
Diagnostic Devices·1,148 affected·Jan 4, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test ...
Diagnostic Devices·76,107 affected·Jan 4, 2017
High RiskFDA
Immuno-mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Diagnostic Devices·630 affected·Dec 27, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in ...
Diagnostic Devices·1,379 affected·Dec 21, 2016
High RiskFDA
Ortho-clinical Diagnostics
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concen...
Diagnostic Devices·659,957 affected·Dec 20, 2016
High RiskFDA
Dicom Grid Inc
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnosti...
Diagnostic Devices·209 affected·Dec 16, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurem...
Diagnostic Devices·11,165 affected·Dec 16, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to pr...
Diagnostic Devices·35 affected·Dec 16, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Comput...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Comp...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·88 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·102 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·34 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp...
Diagnostic Devices·18 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·51 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed To...
Diagnostic Devices·1 affected·Dec 13, 2016
High RiskFDA
Siemens Medical Solutions Usa Inc.
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo...
Diagnostic Devices·41 affected·Dec 13, 2016
High RiskFDA
Great Basin Scientific, Inc.
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnos...
Diagnostic Devices·32 affected·Dec 12, 2016
High RiskFDA
Medline Ind
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubri...
Diagnostic Devices·12,024 affected·Dec 12, 2016
High RiskFDA
Polymer Technology Systems
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Diagnostic Devices·8,285 affected·Dec 2, 2016
High RiskFDA
Merit Medical Systems, Inc.
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and ...
Diagnostic Devices·335 affected·Dec 1, 2016
CriticalFDA
Biomerieux Sa
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for th...
Diagnostic Devices·3,723 affected·Nov 23, 2016
CriticalFDA
Biomerieux Sa
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device a...
Diagnostic Devices·3,723 affected·Nov 23, 2016
High RiskFDA
Carestream Health Inc
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or flu...
Diagnostic Devices·14 affected·Nov 21, 2016
High RiskFDA
Shimadzu Medical Systems
Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnosti...
Diagnostic Devices·13 affected·Nov 20, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (...
Diagnostic Devices·4,705 affected·Nov 18, 2016
High RiskFDA
Roche Molecular Systems, Inc.
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA fro...
Diagnostic Devices·24 affected·Nov 16, 2016
RecallFDA
Perkinelmer Health Sciences, Inc.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Diagnostic Devices·79 affected·Nov 16, 2016
RecallFDA
Orasure Technologies, Inc.
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the q...
Diagnostic Devices·4 affected·Nov 10, 2016
RecallFDA
Helena Laboratories, Inc.
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGN...
Diagnostic Devices·43 affected·Nov 7, 2016
RecallFDA
Diagnostic Hybrids, Inc.
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Diagnostic Devices·26 affected·Oct 26, 2016
High RiskFDA
Beckman Coulter Inc.
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Acces...
Diagnostic Devices·357 affected·Oct 24, 2016
RecallFDA
Euro Diagnostica Ab
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) a...
Diagnostic Devices·4 affected·Oct 21, 2016
RecallFDA
Euro Diagnostica Ab
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the ...
Diagnostic Devices·6 affected·Oct 21, 2016
RecallFDA
Euro Diagnostica Ab
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of an...
Diagnostic Devices·4 affected·Oct 21, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·18,733 affected·Oct 19, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP s...
Diagnostic Devices·30,222 affected·Oct 19, 2016
High RiskFDA
Beckman Coulter Inc.
AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer sys...
Diagnostic Devices·2,367 affected·Oct 19, 2016
High RiskFDA
Abbott Laboratories
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Diagnostic Devices·26 affected·Oct 11, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Diagnostic Devices·37,437 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Diagnostic Devices·69,781 affected·Oct 5, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 a...
Diagnostic Devices·139 affected·Sep 27, 2016
High RiskFDA
Ge Healthcare, Llc
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
Diagnostic Devices·58 affected·Sep 16, 2016
High RiskFDA
Tem Systems Inc
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the ...
Diagnostic Devices·637 affected·Sep 13, 2016