Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide Recalled by Ortho Clinical Diagnostics Inc Due to VITROS Chemistry Products CKMB Slides Potential for Falsely...
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 Inc directly.
Affected Products
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
Quantity: Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units
Why Was This Recalled?
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho Clinical Diagnostics Inc
Ortho Clinical Diagnostics Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report