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U.S. Department of Health and Human Services

Class 2 Device Recall Roche VALP2

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  Class 2 Device Recall Roche VALP2 see related information
Date Initiated by Firm April 30, 2007
Date Posted June 09, 2007
Recall Status1 Terminated 3 on December 17, 2007
Recall Number Z-0920-2007
Recall Event ID 37796
510(K)Number K060690  
Product Classification Enzyme immunoassay - Product Code LEG
Product Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
Code Information Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008, and 144208, exp. 6/30/2008
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
For Additional Information Contact
800-428-2336
Manufacturer Reason
for Recall		 Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
FDA Determined
Cause 2		 Other
Action Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.
Quantity in Commerce 992
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 = LEG and Original Applicant = ROCHE DIAGNOSTICS CORP.
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