| Class 2 Device Recall ADVIA Centaur Systems Insulin Calibrator | |
Date Initiated by Firm | April 05, 2017 |
Date Posted | April 19, 2017 |
Recall Status1 |
Terminated 3 on April 02, 2019 |
Recall Number | Z-2085-2017 |
Recall Event ID |
76992 |
510(K)Number | K021535 |
Product Classification |
Calibrator, secondary - Product Code JIT
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Product | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899 |
Code Information |
Kit Lots Ending: 59, 67, 70, 74 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
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For Additional Information Contact | 508-668-5000 |
Manufacturer Reason for Recall | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Siemens issued a UMDC to ADVIA Centaur/XP/XPT/CP IRI customers on April 5, 2017. They were informed of the issue & that they may continue use of current product but should discontinue when corrected product is available (reagent lots ending in 201 with cal lots ending in 02). A shift down will occur with the corrected product. BioRad control ranges will be posted to QCnet.com for the corrected reagents. |
Distribution | US
OUS: 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, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany,
Denmark, Estonia, Spain, Finland, France, Great Britain, Hungary, Italy, Luxembourg, Latvia,
Netherlands, Norway, Greece, Croatia, Poland, Portugal, Romania, Sweden, Slovak Republic,
Turkey |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JIT
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