Use cautionMedical device recall · FDA · Published July 10, 2024
Ortho-Clinical VITROS XT ALB-TP Slides Recall: Dust May Cause Sodium Test Errors
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.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/54675-ortho-clinical-vitros-xt-alb-tp-slides-recall-dust-may.
“Ortho-Clinical VITROS XT ALB-TP Slides Recall: Dust May Cause Sodium Test Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54675-ortho-clinical-vitros-xt-alb-tp-slides-recall-dust-may. Based on FDA recall #Z-2684-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2684-2024%22&limit=1).
The FDA announced on July 10, 2024, that Ortho-Clinical Diagnostics is recalling The VITROS XT Chemistry Products ALB-TP Slides due to a hazard of potentially inaccurate sodium test results. The agency stated the issue may lead to incorrect diagnosis or treatment.
How to tell if you have it
Brand: Ortho-Clinical
Product: The VITROS XT Chemistry Products ALB-TP Slides
UPC: 10758750031771
The hazard
The FDA said the slides may shed dust and debris that can settle on sodium slides, potentially causing biased Na+ results. This contamination could result in falsely elevated or reduced results, leading to incorrect diagnosis, treatment, or serious patient health hazards such as hypernatremia or hyponatremia. The issue may also generate error codes preventing the analyzer from processing assays.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has had 53 other recalls on record since July 10, 2017. Recent similar recalls include Ortho-Clinical VITROS LAC Slides Recall (July 29, 2025) and Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025). Other recent recalls of similar products include Vivoo Test Strips Recall (Nov. 22, 2025), Siemens Healthcare Syva Emit Tox Serum Calibrators Recall (June 26, 2026), and Siemens Healthcare Syva Emit Disopyramide Assay Recall (June 26, 2026).
How to tell if you have this one
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.
Brand
Ortho-Clinical
Product
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Slide Model
Verify the model number on the slide to confirm it is affected by this recall.
Contact Lab for Results
If you have used the affected slides, contact your lab to check if sodium test results may be inaccurate.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2684-2024 (July 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2684-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.