Z-2129-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2400 units
Product Description
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
Reason for Recall
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden , The Netherlands, United Kingdom.
Code Information
UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023