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Recall Observatory FDA recall evidence

Device product

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 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-1077-2016

February 04, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 73263
Status
Terminated
Classification
Class II
Quantity
15224 (2-pack)
Official record key
device-enforcement:Z-1077-2016

Official wording

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

Code information: Lot codes/Exp Date: 87226A42 May 9, 2016; 55811 A42 May 9, 2016; 53650A42 May 9, 2016; 53624A42 May 9, 2016; 15612A43 November 27, 2016; 17909A43 November 27, 2016; 22868A43 November 27, 2016; 45084A43 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