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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Chemistry Systems A1c_3 Calibrators

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  Class 2 Device Recall ADVIA Chemistry Systems A1c_3 Calibrators see related information
Date Initiated by Firm August 06, 2014
Date Posted September 15, 2014
Recall Status1 Terminated 3 on February 28, 2017
Recall Number Z-2643-2014
Recall Event ID 68871
510(K)Number K081895  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD
ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems.
The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
Code Information Lots 3HD044 (exp. 11/01/2015), and 3LD068 (exp. 01/01/2016)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-524-2955
Manufacturer Reason
for Recall		 The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.
FDA Determined
Cause 2		 Software design
Action Siemens sent an Urgent Field Safety Notice dated August 2014 to all affected consignees on August 6, 2014 via Federal Express. The letter instructed consignees to discontinue use and discard calibrator lots 3HD044 and 3LD068. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Distribution of the Urgent Field Safety Notices to foreign consignees was determined at the country level. For questions regarding this recall call 914-524-2955.
Quantity in Commerce Domestic: 1122 kits; Foreign: 236 kits
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Austria, Brazil, Canada, China, Colombia, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Istanbul, Italy, Lithuania, Mexico, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Korea, Spain, Switzerland, Thailand, Uruguay, Vietnam, and Zambia.
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 = JIX and Original Applicant = SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
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