Category

Diagnostic Devices Recalls

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

1,863 recalls
High RiskFDA
Biofire Defense
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use wi...
Diagnostic Devices·130 affected·Jul 10, 2025
High RiskFDA
Biomerieux, Inc.
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of inst...
Diagnostic Devices·235,269 affected·Jun 26, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Diagnostic Devices·1 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Diagnostic Devices·177 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Diagnostic Devices·451 affected·Jun 25, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Diagnostic Devices·1 affected·Jun 25, 2025
High RiskFDA
Caris Life Sciences
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor m...
Diagnostic Devices·1 affected·Jun 17, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-t...
Diagnostic Devices·2,017 affected·Jun 12, 2025
High RiskFDA
Sedecal Sa
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Diagnostic Devices·1,198 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 So...
Diagnostic Devices·37,429 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 So...
Diagnostic Devices·36,005 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Diagnostic Devices·56 affected·Jun 10, 2025
High RiskFDA
Diagnostica Stago, Inc.
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and...
Diagnostic Devices·939 affected·May 21, 2025
High RiskFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Diagnostic Devices·34 affected·May 16, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: ...
Diagnostic Devices·1,958 affected·May 9, 2025
High RiskFDA
Copan Italia
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Diagnostic Devices·81,600 affected·May 2, 2025
High RiskFDA
Remel, Inc
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic d...
Diagnostic Devices·70 affected·May 1, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Diagnostic Devices·60 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Diagnostic Devices·4 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.
Diagnostic Devices·5 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
Diagnostic Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Diagnostic Devices·400 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Diagnostic Devices·2 affected·Apr 24, 2025
RecallFDA
Beckman Coulter Ireland, Inc.
Apo B Reagent, REF: OSR6143
Diagnostic Devices·2,747 affected·Apr 23, 2025
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Diagnostic Devices·231 affected·Apr 23, 2025
High RiskFDA
C-rad Positioning Ab
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Ca...
Diagnostic Devices·44 affected·Apr 22, 2025
High RiskFDA
Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invit...
Diagnostic Devices·89 affected·Apr 16, 2025
High RiskFDA
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
Diagnostic Devices·4 affected·Apr 9, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Diagnostic Devices·56 affected·Mar 24, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coul...
Diagnostic Devices·0 affected·Mar 20, 2025
High RiskFDA
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions...
Diagnostic Devices·136 affected·Mar 17, 2025
High RiskFDA
Philips North America Llc
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Diagnostic Devices·83 affected·Mar 10, 2025
High RiskFDA
Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Diagnostic Devices·4,387 affected·Mar 6, 2025
CriticalFDA
Ge Medical Systems, Llc
Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VG...
Diagnostic Devices·12,808 affected·Mar 6, 2025
High RiskFDA
Fisher Diagnostics
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Diagnostic Devices·1,699 affected·Mar 6, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Produ...
Diagnostic Devices·2,776,416 affected·Mar 4, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Produ...
Diagnostic Devices·592,320 affected·Mar 4, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Diagnostic Devices·10,000 affected·Feb 27, 2025
High RiskFDA
Microbiologics Inc
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalo...
Diagnostic Devices·6 affected·Feb 20, 2025
High RiskFDA
Remel, Inc
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Diagnostic Devices·316 affected·Feb 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64...
Diagnostic Devices·2,161 affected·Feb 11, 2025
High RiskFDA
American Contract Systems Inc
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Diagnostic Devices·170 affected·Feb 6, 2025
High RiskFDA
Microbiologics Inc
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Diagnostic Devices·16 affected·Jan 20, 2025