Ortho Clinical Diagnostics VITROS CKMB Slides May Give False High Results
Ortho Clinical Diagnostics recalls VITROS CKMB Slides that may cause falsely elevated results due to CK-MM interference. Affected products include 60-slide and 18-slide cartridges with specific product codes and lot numbers.
Lower-risk recall
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
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What happened, in plain English
Ortho Clinical Diagnostics is recalling VITROS CKMB Slides that can cause false high results in blood tests due to interference with CK-MM. This affects specific slide cartridges sold with certain product codes and lot numbers. Users should check their product details to see if they are affected. Read more at govinfonow.com/recall/63675-ortho-clinical-diagnostics-vitros-ckmb-slides-may-give-false-high.
Source Summary by GovInfoNow · govinfonow.com/recall/63675-ortho-clinical-diagnostics-vitros-ckmb-slides-may-give-false-high · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0770-2021
Cite this page
“Ortho Clinical Diagnostics VITROS CKMB Slides May Give False High Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63675-ortho-clinical-diagnostics-vitros-ckmb-slides-may-give-false-high. Based on FDA recall #Z-0770-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0770-2021%22&limit=1).
Why it’s dangerous
The slides may produce false high readings for creatine kinase MB (CK-MB) in blood tests due to interference from CK-MM. This could lead to incorrect health assessments if the test results are used for diagnosis.
Who’s affected
Lab users who test blood with VITROS CKMB Slides may be affected. Those using the specific 60-slide and 18-slide cartridges with product codes 8058232 and 8001133 are most at risk.
How to tell if you have this one
Check for product codes 8058232 (60-slide cartridge) or 8001133 (18-slide cartridge). Also look for lot numbers 0230, 0231, 0233, 0235, 0239, 0245, 0246, 0248, or 0261.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
What to do — step by step
Check Product Details
Identify your VITROS CKMB Slides by product code (8058232 or 8001133) and lot number (0230, 0231, 0233, 0235, 0239, 0245, 0246, 0248, or 0261).
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 Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia,…” 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 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these slides?
No, the recall does not require stopping use immediately. Affected users should check their product details to confirm if they are affected.
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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-0770-2021 (December 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0770-2021 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.