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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Recalled March 14, 2018 · FDA recall Z-0915-2018 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class II
Units
102
Sold at
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.
Description
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.
Product
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →