Ortho Clinical Di: VITROS XT ALB-TP Slides May Give False Protein Results
Ortho Clinical Diagnostics recalls VITROS XT ALB-TP Slides due to potential false protein results. Affected units include all current, future, and past lots of product code 6844293.
Lower-risk recall
Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides
Contact the company
What happened, in plain English
Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides because they may give false protein test results. This could lead to incorrect health assessments if used in medical testing. Read more at govinfonow.com/recall/63655-ortho-clinical-di-vitros-xt-alb-tp-slides-may-give.
Source Summary by GovInfoNow · govinfonow.com/recall/63655-ortho-clinical-di-vitros-xt-alb-tp-slides-may-give · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0845-2021
Cite this page
“Ortho Clinical Di: VITROS XT ALB-TP Slides May Give False Protein Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63655-ortho-clinical-di-vitros-xt-alb-tp-slides-may-give. Based on FDA recall #Z-0845-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0845-2021%22&limit=1).
Why it’s dangerous
The slides may produce false protein measurements when used with certain blood tests, leading to inaccurate health assessments. This interference occurs due to eltmobag in the test samples.
Who’s affected
Medical labs using VITROS XT 3400 or 7600 systems with ALB-TP Slides (product code 6844293) are affected. Patients receiving tests using these slides may be at risk of incorrect results.
How to tell if you have this one
Check for product code 6844293 on VITROS XT ALB-TP Slides. All current, future, and past lots are affected. The slides are used in VITROS XT 3400 and 7600 chemistry systems.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0844-2021 | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292; All Current, Future and Past Lots UDI: 10758750004850 | US= 223,788 ; OUS:=168,120 Totlal: 491,908 |
| Z-0845-2021 | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293; All Current, Future and Past Lots UDI: 10758750031771 | US=9802; OUS: 1298 Total: 11,100 |
What to do — step by step
Check Product Code
Look for product code 6844293 on the slides to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.” 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 terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0845-2021 (December 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0845-2021 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.