Class 2 Device Recall ADVIA Chemistry A1c_3 Calibrators

• Date Initiated by Firm: July 30, 2013
• Date Posted: September 03, 2013
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-2135-2013
• Recall Event ID: 65868
• 510(K)Number: K081895
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• Product: 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 tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.; ; For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.
• Code Information: Lots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014)
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: 914-524-2955
• Manufacturer Reason for Recall: 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..
• FDA Determined 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 them how to deal with customer questions. Customers were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative for questions. For questions regarding this recall call 914-524-2955.
• Quantity in Commerce: 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, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LCP and Original Applicant = SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS