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Recall Observatory FDA recall evidence

Device product

VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

Z-0914-2018

September 22, 2017

Class II

Product summary

Firm
Ortho-Clinical Diagnostics
Event
Event 79155
Status
Terminated
Classification
Class II
Quantity
196
Official record key
device-enforcement:Z-0914-2018

Official wording

Reason: This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

Code information: Catalog# 6802330 Lot# L5619

Distribution pattern: Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.