Z-2424-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- July 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 580 units
Product Description
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Reason for Recall
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Distribution Pattern
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Code Information
All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.