The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein

FDA device recall Z-2684-2024 · posted 2024-08-16 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Reason for recall

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 degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

Action taken

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 Chemistry Products TP Slides. We have verified through internal testing that the individual ALB and TP slides do not show the same behavior as the XT ALB-TP slides. Upon receipt of this notification, please perform the cleaning steps listed in Appendix 1: VITROS XT System Cleaning Focus, on your VITROS XT 3400 and/or XT 7600 System(s) to remove any dust and debris which may have accumulated in the MicroSlide Subsystem. Perform the cleaning steps listed in Appendix 1: VITROS XT System Cleaning Focus again on your VITROS XT 3400 and/or XT 7600 System(s) after your laboratory has discontinued using VITROS XT ALB-TP Slides. Customers may continue to use VITROS XT ALB-TP Slides until the replacement VITROS ALB Slides and VITROS TP Slides are received. After receipt of the replacement VITROS Slides, and on completion of any necessary crossover studies / validation, please discontinue using, render unusable, and discard your remaining inventory of VITROS XT ALB-TP Slides. cleaning of the MicroSlide Subsystem on your VITROS XT 3400 and/or VITROS XT 7600 System(s). Refer to Appendix 1: VITROS XT System Cleaning Focus for a list of specific areas which have been observed to accumulate dust and debris shed from VITROS XT ALB-TP Slides. " Prepare your laboratory s transition from using VITROS XT ALB-TP Slides to the VITROS Chemistry Products ALB Slides and VITROS TP Slides products, including

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CIX

Quantity affected

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 Nethe

Date initiated

2024-07-10

Date posted

2024-08-16

Location

Rochester, NY