FDA Device Recalls

Class IIITerminated

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

Ortho-Clinical Diagnostics, Inc.

Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

October 15, 2021 · DeviceView details →

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918

Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems