Z-2085-2017 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc — East Walpole, MA

Recall Details

Product Type
Devices
Report Date
May 24, 2017
Initiation Date
April 5, 2017
Termination Date
April 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899

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.

Distribution Pattern

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

Code Information

Kit Lots Ending: 59, 67, 70, 74