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Recall Observatory FDA recall evidence

Device product

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

Z-0471-2021

October 16, 2020

Class III

Product summary

Firm
Ortho Clinical Diagnostics Inc
Event
Event 86669
Status
Ongoing
Classification
Class III
Quantity
10788 total: US 4680; OUS 6108
Official record key
device-enforcement:Z-0471-2021

Official wording

Reason: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Code information: Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures