Recall Z-0515-2018 ยท CHP Radioimmunoassay, Estradiol
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
| Date | Jun 7, 2017 |
| Status | Terminated |
| 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). |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall letter dated June 7, 2017 was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States who have received ADVIA Centaur Systems Calibrator 30 kit lot ending in 21(C3021). These letters instruct customers who operate the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems to discontinue use of C3021 . The letters inform customers that Calibrator 30 kit lots ending in 20 (C3020) and 23 (C3023) are not impacted and can be used. The letters inform customers who operate ADV |
| Quantity | 5992 units (US and OUS) |
| Distribution | US and OUS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100293 | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 Siemens Heatlhcare Diagnostics, Inc., Mar 19, 2010 |