Recall Z-0930-2014 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
| Date | Feb 4, 2014 (initiated Dec 18, 2013) |
| Status | Terminated |
| Reason | ADVIA Centaur Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots. |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare Diagnostics Customer Notification notice was sent to affected Siemens Healthcare Diagnostic customers in the United States on December 18, 2013.. The notifications inform customers that Siemens Healthcare Diagnostics received customer feedback regarding the performance of the ADVIA Centara Systems Phenytoin assay, indicating that the assay was recovering higher relative to the performance of other assays in proficiency studies. Siemens internal investigation confirmed the positive bias for Calibrator N lot CN 57 in the ADVIA Centaur Systems Phenytoin assay. This lot has expi |
| Quantity | 1294 (144 units US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011393 | RANDOX PHENYTOIN Randox Laboratories, Ltd., Dec 4, 2001 |