Z-1420-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- January 4, 2017
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9076
Product Description
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.
Reason for Recall
DHEA-S causes falsely elevated progesterone results.
Distribution Pattern
US Nationwide distribution including Puerto Rico
Code Information
LKPW1 kit lot 0245 LKPW1 kit lot 0246 LKPW1 kit lot 0247 LKPW1 kit lot 0248 LKPW1 kit lot 0249