ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Reported: February 14, 2018 Initiated: June 7, 2017 #Z-0515-2018
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).
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 5992 units (US and OUS)
- Distribution
- US and OUS.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 5992 units (US and OUS).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0515-2018.
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