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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur Systems Calibrator A

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  Class 2 Device Recall Siemens ADVIA Centaur Systems Calibrator A see related information
Date Initiated by Firm January 10, 2017
Create Date February 25, 2017
Recall Status1 Terminated 3 on July 16, 2019
Recall Number Z-1255-2017
Recall Event ID 76285
510(K)Number K961510  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product Siemens ADVIA Centaur Systems Calibrator A Kits,
Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack)
Cat No. 04800840, SMN 10285905 (6 pack - REF)
Code Information Lot Numbers: 07996A90 21172A90 27221A90 44366A90 63785A90   Exp. Date: 2017/07/24
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 FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Siemens issued Urgent Medical Device Recall (UMDR) sent to Siemens Healthcare Diagnostics customers in the United States on January 10, 2017 to be delivered to customers on January 11, 2017. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on January 10, 2017. The customer distribution included all customers that have received ADVIA Centaur Systems Calibrator A kit lots ending in 90 and ADVIA Centaur FT4 ReadyPacks. These notices inform the customer a negative bias has been confirmed for the ADVIA Centaur FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. ADVIA Centaur FT4 assay customers using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems were directed to discontinue the use of Calibrator A kit lots ending in 90 and instead use Calibrator A kit lots ending in 91 and above to calibrate the FT4 assay.
Quantity in Commerce 1937 kits
Distribution Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JJX and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
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