Z-0515-2018 Class II Terminated
FDA device recall Z-0515-2018 was initiated by Siemens Healthcare Diagnostics, Inc on June 7, 2017 and is designated Class II. Reason for recall: 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 Calib… The recall status is terminated (terminated May 8, 2019). Affected quantity: 5992 units (US and OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- June 7, 2017
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5992 units (US and OUS)
Product Description
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Reason for Recall
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).
Distribution Pattern
US and OUS.
Code Information
Lot Numbers: 00387A21, 16673A21, 36243A21; 00388A21, 15448A21, 51211A21; 20640A21; 51024A21. Expiration Date: 2018-03-08