—#143652

Product

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems

FDA product code: JIX — Calibrator, Multi-Analyte Mixture
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K932955
Affected lot / code info: Lot code/ Exp.Date: 86344A42 May 9, 2016; 55437A42 May 9, 2016; 54801A42 May 9, 2016; 53651A42 May 9, 2016; 53625A42 May 9, 2016; 15610A43 November 27, 2016; 18375A43 November 27, 2016; 24990A43 November 27, 2016; 38988A43 November 27, 2016

Why it was recalled

ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Correction. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA

Timeline

Recall initiated: 2016-02-04
Posted by FDA: 2016-03-08
Terminated: 2017-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143652. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.