Recall Z-2424-2021 ยท MOI System, Test, Immunological, Antigen, Tumor
Siemens Healthcare Diagnostics, Inc
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
| Date | Jul 6, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare issued Urgent Medical Device Correction (UMDC) via FedEx beginning on 07/06/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 07/06/2021. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Change the BR assay Pack Calibration Interval on each Atellica IM analyzer from 10 days to 3 days. See Additional Information for instructions on changing the Pac |
| Quantity | 580 units |
| Distribution | Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY Chiron Diagnostics Corp., Oct 15, 1998 |