Recall Z-1421-2017 ยท JLS Radioimmunoassay, Progesterone
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
| 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 | 11963 |
| 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 |