Recall Z-2410-2012— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-2410-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-07

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2012-08-07, terminated 2014-02-26. It names one FDA 510(k) clearance: K904714. Product: ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Reason: ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40.

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class III
Status: Terminated
Initiated: 2012-08-07
Terminated: 2014-02-26
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K904714 — CIBA CORNING ACS PROLACTIN IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1990-11-07

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 FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems

Reason for recall

ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

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