Device product
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 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-1079-2016
Product summary
- Event
- Event 73263
- Status
- Terminated
- Classification
- Class II
- Quantity
- 519 pack
- Official record key
device-enforcement:Z-1079-2016
Official wording
Reason: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
Code information: Lot codes/Exp Date: 91005A42 May 9, 2016; 53698A42 May 9, 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
ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay