Class 2 Device Recall Roche Elecsys Folate II

• Date Initiated by Firm: September 15, 2006
• Date Posted: September 29, 2006
• Recall Status: Terminated on April 30, 2008
• Recall Number: Z-1550-06
• Recall Event ID: 36157
• 510(K)Number: K043318
• Product Classification: Folate analyzer - Product Code CGN
• Product: Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
• Code Information: Lots 175646 and 174558.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-428-2336
• Manufacturer Reason for Recall: Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.
• FDA Determined Cause: Other
• Action: Consignees were informed via letter dated 9/15/06 to perform Folate assays in batch mode and to run controls and liquid flow cleaning upon completion of each batch run. Distributors were requested to notify their customers.
• Quantity in Commerce: 5688 units
• Distribution: Nationwide.
• 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 = CGN