59 results
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Sources: EU EUDAMED, US FDA
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***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during clinical applications Material Number: 10308194
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·September 12, 2023
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·September 12, 2023
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·June 5, 2023
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code CEO·April 24, 2025
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Recall
Open, Classified
·Bio-Rad Laboratories·Product code OYX·February 15, 2024
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
FDA Recall
Open, Classified
·LINK BIO CORP·Product code HWT·June 27, 2024
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code MID·February 28, 2023
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025
Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc·Product code JJE·January 10, 2019
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·April 14, 2022
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·April 21, 2020
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·September 17, 2021
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022
CMV IgM EIA, in vitro diagnostic.
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LFZ·October 19, 2022
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
FDA Recall
Open, Classified
·Bio-Rad Laboratories, Inc.·Product code LIP·September 17, 2021