Recall Z-2085-2017 ยท JIT Calibrator, Secondary
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
| Date | Apr 19, 2017 (initiated Apr 5, 2017) |
| Status | Terminated |
| Reason | 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 | 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, Gua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021535 | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR Bayer Diagnostics Corp., Jun 27, 2002 |