Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Chemistry Products CKMB Slides Recalled by Ortho-Clinical Diagnostics Due to The Spanish and Swedish language versions of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics directly.
Affected Products
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Quantity: N/A
Why Was This Recalled?
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report