VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Reported: May 6, 2020 Initiated: March 10, 2020 #Z-1834-2020
Product Description
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Reason for Recall
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Details
- Recalling Firm
- Ortho Clinical Diagnostics
- Units Affected
- 3181
- Distribution
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468. Recalled by Ortho Clinical Diagnostics. Units affected: 3181.
Why was this product recalled? ▼
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Low. Recall number: Z-1834-2020.
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