Z-1418-2017 Class II Terminated
FDA device recall Z-1418-2017 was initiated by Siemens Healthcare Diagnostics, Inc on January 4, 2017 and is designated Class II. Reason for recall: DHEA-S causes falsely elevated progesterone results. The recall status is terminated (terminated July 18, 2019). Affected quantity: 76,107.
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
- 76,107
Product Description
ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used 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
SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277; SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277; SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276