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U.S. Department of Health and Human Services

Class 2 Device Recall Roche/Hitachi Glucose Hexokinase Reagent

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  Class 2 Device Recall Roche/Hitachi Glucose Hexokinase Reagent see related information
Date Initiated by Firm April 12, 2006
Date Posted May 25, 2006
Recall Status1 Terminated 3 on October 16, 2006
Recall Number Z-0899-06
Recall Event ID 35023
510(K)Number K854025  
Product Classification Hexokinase, Glucose - Product Code CFR
Product Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
Code Information Lot 672652; exp. 6/30/2007.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
FDA Determined
Cause 2		 Other
Action A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.
Quantity in Commerce 269 kits
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 = CFR and Original Applicant = BOEHRINGER MANNHEIM CORP.
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