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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.

Z-0515-2018

June 07, 2017

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 78645
Status
Terminated
Classification
Class II
Quantity
5992 units (US and OUS)
Official record key
device-enforcement:Z-0515-2018

Official wording

Reason: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).

Code information: Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08

Distribution pattern: US and OUS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).