Ortho-Clinical recalls VITROS XT ALB-TP Slides due to dust shedding that may cause inaccurate sodium test results, risking incorrect diagnoses and treatment. All current and expired slides are affected.
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.
Ortho-Clinical is recalling VITROS XT ALB-TP Slides because dust and debris can shed during use, potentially causing sodium test results to be inaccurate. This could lead to incorrect diagnoses, wrong treatments, or serious health issues like hypernatremia or hyponatremia.
Dust and debris from the slides may settle on sodium test slides during processing, causing inaccurate sodium measurements. This can lead to results that are too high or too low, potentially causing serious health issues like hypernatremia or hyponatremia if not corrected.
Lab users who handle VITROS XT ALB-TP Slides for blood tests are most at risk. Patients receiving sodium test results from affected slides could experience incorrect diagnoses or treatment.
Check for VITROS XT ALB-TP Slides with model number 6844293 or UDI/GTIN# 10758750031771. All current and expired slides are affected by this issue.
Verify the model number on the slide to confirm it is affected by this recall.
If you have used the affected slides, contact your lab to check if sodium test results may be inaccurate.
Dust and debris from the slides may shed during use, potentially settling on sodium test slides and causing inaccurate sodium measurements.
Yes, if the sodium test results are inaccurate, it could lead to incorrect diagnoses or treatments, potentially causing serious health issues like hypernatremia or hyponatremia.
No, but you should check if your lab has used affected slides and contact them to verify sodium test results.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2684-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2684-2024 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
