Recall Z-1421-2017— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1421-2017
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: IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid 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

IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid 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.