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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Calibrator 30

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 Class 2 Device Recall ADVIA Centaur Calibrator 30see related information
Date Initiated by FirmJune 07, 2017
Create DateFebruary 04, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall NumberZ-0515-2018
Recall Event ID 78645
510(K)NumberK100293 
Product Classification Radioimmunoassay, estradiol - Product Code CHP
ProductADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Code Information Lot Numbers: 00387A21, 16673A21, 36243A21;  00388A21, 15448A21, 51211A21;  20640A21; 51024A21.  Expiration Date: 2018-03-08     
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer 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).
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 ADVIA Centaur CP systems to continue using their inventory of C3021, as they are not impacted by this issue. All affected domestic customers were sent a hard copy of the Urgent Medical Device Recall via Federal Express. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Recall letter.
Quantity in Commerce5992 units (US and OUS)
DistributionUS and OUS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CHP
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