Recall Z-0164-2015— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0164-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-09-26, terminated 2016-01-29. It names one FDA 510(k) clearance: K932955. Product: Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref). Reason: Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-26
Terminated: 2016-01-29
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

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)

Reason for recall

Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

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