Recall Z-2135-2013 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run test
| Date | Sep 3, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected.. |
| Root cause | Software design |
| Action | Siemens sent an Urgent Medical Device Correction letter dated July 30, 2013, to all affected customers via FedEx (for US consignees). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any of the affected reagent kit lots. Customers werealso requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing t |
| Quantity | US: 1546 units; Foreign: 518 units |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS Siemens Medical Solutions Diagnostics, Jan 8, 2009 |