Ortho Clinical Diagnostics recalls VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
- Recall date
- March 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1834-2020
- FDA classification
- Class III
- Brand / firm
- Ortho Clinical Diagnostics
- Sold / distributed
- US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
Why it was recalled
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
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