Device product
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
Z-1420-2017
Product summary
- Event
- Event 76212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9076
- Official record key
device-enforcement:Z-1420-2017
Official wording
Reason: DHEA-S causes falsely elevated progesterone results.
Code information: LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249
Distribution pattern: US Nationwide distribution including Puerto Rico
Derived failure modes
-
Unknown
DHEA-S causes falsely elevated progesterone results.