Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use Recalled by Ortho Clinical Diagnostics Inc Due to Product instability; biased ALKP values obtained from VITROS...
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 Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
Quantity: 10788 total: US 4680; OUS 6108
Why Was This Recalled?
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
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