Recall Z-1419-2017 ยท JLS Radioimmunoassay, Progesterone
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
| Date | Jan 4, 2017 |
| Status | Terminated |
| Reason | DHEA-S causes falsely elevated progesterone results. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support. |
| Quantity | 1148 |
| Distribution | US Nationwide distribution including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp., Aug 2, 1993 |