8 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·July 19, 2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)
FDA Recall
Open, Classified
·Forbes Rehab Services Inc·Product code ILQ·October 11, 2021
NaviCare Nurse Call/Voalte Nurse Call
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code ILQ·May 31, 2022
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
FDA Recall
Open, Classified
·Tobii Dynavox Llc·Product code ILQ·February 24, 2023
McKesson Cardiology Hemo software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024
Change Healthcare Cardiology Hemodynamics software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024
Change Healthcare Cardiology Hemo software
FDA Recall
Open, Classified
·A L I Technologies Ltd·Product code MWI·December 2, 2024