Device product

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.

Z-1418-2017

January 04, 2017

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc
Event: Event 76212
Status: Terminated
Classification: Class II
Quantity: 76,107
Official record key: device-enforcement:Z-1418-2017

Official wording

Reason: DHEA-S causes falsely elevated progesterone results.

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

Distribution pattern: US Nationwide distribution including Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

DHEA-S causes falsely elevated progesterone results.