Z-1834-2020 Class III Terminated
FDA device recall Z-1834-2020 was initiated by Ortho Clinical Diagnostics on March 10, 2020 and is designated Class III. Reason for recall: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. The recall status is terminated (terminated September 26, 2022). Affected quantity: 3181.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- March 10, 2020
- Termination Date
- September 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3181
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.
Distribution Pattern
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.
Code Information
UDI: 10758750005147; Lot Number: 2340