Recall Z-1121-2013 ยท JIS Calibrator, Primary
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
| Date | Apr 15, 2013 (initiated Mar 13, 2013) |
| Status | Terminated |
| Reason | Negative bias in patient samples for Vitamin D |
| Root cause | No Marketing Application |
| Action | Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the rec |
| Quantity | 372 pk Cals |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.