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Recall Observatory FDA recall evidence

Device 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

Z-1078-2016

February 04, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 73263
Status
Terminated
Classification
Class II
Quantity
6455 (6 pack)
Official record key
device-enforcement:Z-1078-2016

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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