Recall Z-0524-2009 ยท JLS Radioimmunoassay, Progesterone
Siemens Medical Solutions Diagnostics
IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) 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 | Dec 23, 2008 (initiated Jul 21, 2008) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.). |
| Root cause | Other |
| Action | Siemens initiated the recall on 07/22/2008 by forwarding A Customer Bulletin by fax or mail to all affected Siemens Healthcare Diagnostic Branches for communication with the affected customers. The Customer Bulletin informed their customers that the firm is conducting a field correction and requested that they discontinue using any IMMULITE/IMMULITE 1000 kit lot prior to LKPG 1,5 330. They were also instructed to complete attached Completion Notification Form and return to their local Siemens Healthcare office or distributor as soon as possible. The were informed that replacement kits wil |
| Quantity | 12,908 |
| Distribution | Worldwide Distribution --- including USA and countries of Argentina, Aruba, Australia, Austria, Bangladesh, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944211 | IMMULITE PROGESTERONE Diagnostic Products Corp., Dec 19, 1994 |