Siemens Healthcare Diagnostics, Inc Recall 88431
Description: Atellica IM BR 27.29 (BR) Assay 250 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: 10995477
Siemens Healthcare Diagnostics, Inc Recall 88431 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2425-2021 |
| Event ID | 88431 |
| Event Description | Atellica IM BR 27.29 (BR) Assay 250 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: 10995477 |
| Product Type | Devices |
| Distribution | Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam |
| Quantity | 437 units |
| Recall 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 |
| Device Classification | 20210915 |
| Device Code Info | All lots impacted Kit lot numbers: 48553255 & 78009255 expiration date 2021-08-03, Lot number: 90311257 expiration date 2021-11-10. |
| Center Classification Date | 20210903 |
| Recall Initiation Date | 20210706 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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