FDA Enforcement
Class II
Ongoing
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- 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: 11206236
Recall: Z-2426-2021
·
Reported September 15, 2021
Enforcement
- Recall Number
- Z-2426-2021
- Event ID
- 88431
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 15, 2021
- Initiation Date
- July 6, 2021
- Classification Date
- September 3, 2021
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- 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: 11206236
Reason
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
Code Info
All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
Distribution
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Quantity
787 units