Recall Z-2290-2019 ยท JLS Radioimmunoassay, Progesterone
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
| Date | Aug 17, 2019 (initiated Jul 10, 2019) |
| Status | Terminated |
| Reason | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters were sent to customers beginning 7/10/19. Actions to be Taken by the Customer 1) Please review this letter with your Medical Director. 2) If interference is suspected, follow your established internal procedures to investigate the interference. 3) Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4) If you have received any complaints of illness or adverse events associated with the products, immediately contact your local Siemens Healthineers Customer Care Center or your loc |
| Quantity | 6633 (4753 additional as of 1/13/20) |
| Distribution | Global distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.