Recall Z-1418-2017— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1418-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-04

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2017-01-04, terminated 2019-07-18. It names one FDA 510(k) clearance: K932955. 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.. Reason: DHEA-S causes falsely elevated progesterone results..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-01-04
Terminated: 2019-07-18
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K932955 — CIBA CORNING ACS PROGESTERONE IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1993-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.