—#152528

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 VistaSystem. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.

FDA product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K932955
Affected lot / code info: 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

Why it was recalled

DHEA-S causes falsely elevated progesterone results.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide distribution including Puerto Rico

Timeline

Recall initiated: 2017-01-04
Terminated: 2019-07-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152528. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.