FDA-Device2018-03-14Class II
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
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.
Sold states
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.
Affected count
349
Manufactured in
1000 Lee Road, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0911-2018Don't want to check this manually?
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