Recall Z-1022-2022 ยท CHP Radioimmunoassay, Estradiol
Siemens Healthcare Diagnostics, Inc.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
| Date | Mar 3, 2022 |
| Status | Open, Classified |
| Reason | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results |
| Root cause | Under Investigation by firm |
| Action | Siemens issued an Urgent Medical Device Correction AIMC 22-03.A.US and Urgent Field Safety Notice AIMC 22-03.A.OUS on 3/3/22. Letter states reason, health risk and action to take: Customers must discontinue use of plasma specimens for testing with the Atellica IM and ADVIA Centaur eE2 assays until further notice. Customers may continue to use the Atellica IM eE2 and ADVIA Centaur eE2 assays with serum specimens. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any |
| Quantity | 230 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.