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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Elecsys Folate II

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  Class 2 Device Recall Roche Elecsys Folate II see related information
Date Initiated by Firm September 15, 2006
Date Posted September 29, 2006
Recall Status1 Terminated 3 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/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
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 2
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 and Original Applicant = ROCHE DIAGNOSTICS CORP.