Recall Z-1419-2017— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1419-2017
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: Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. 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

Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems

Reason for recall

DHEA-S causes falsely elevated progesterone results.

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