ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Reported: May 24, 2017 Initiated: April 5, 2017 #Z-2085-2017
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- 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
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899. Recalled by Siemens Healthcare Diagnostics, Inc.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2085-2017.
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