—#154785

Product

ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.

FDA product code: CFP — Radioimmunoassay, Immunoreactive Insulin
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K021535
Affected lot / code info: Kit Lots Ending: 169, 170, 173, 174

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

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

Timeline

Recall initiated: 2017-04-05
Posted by FDA: 2017-04-19
Terminated: 2019-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154785. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.