Recall Z-2684-2024 ยท CIX Bromcresol Green Dye-Binding, Albumin
Ortho-Clinical Diagnostics, Inc.
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a pol
| Date | Aug 16, 2024 (initiated Jul 10, 2024) |
| Status | Open, Classified |
| Reason | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degr |
| Root cause | Under Investigation by firm |
| Action | QuidelOrtho issued Urgent Product Correction Notification Letter to Distributors and End-Users on 10 July 2024, (Ref. CL2024-139) via FedEx overnight courier and/ or electronically using ORTHO PLUS e-Communications to customers who have been shipped VITROS XT Chemistry Products ALB-TP slides in the last 24 months. Letter states reason for recall, health risk and action to take: Until this issue is resolved, QuidelOrtho will be pausing availability of the VITROS XT ALB-TP Slides and we will shift all affected customers to the individual VITROS Chemistry Products ALB Slides and VITROS Chemist |
| Quantity | 88253 units |
| Distribution | Nationwide. Foreign: Australia Belgium Bermuda Brazil Canada L3R 0B8 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.