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U.S. Department of Health and Human Services

Class 3 Device Recall Mega Diagnostics Alcohol Standard

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  Class 3 Device Recall Mega Diagnostics Alcohol Standard see related information
Date Initiated by Firm September 20, 2006
Date Posted April 14, 2007
Recall Status1 Terminated 3 on June 04, 2012
Recall Number Z-0744-2007
Recall Event ID 37254
510(K)Number K882117  
Product Classification Alcohol Standard - Product Code JIX
Product Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.
Code Information Lot# 509102
Recalling Firm/
Mega Diagnostics
2716 N Main St
Los Angeles CA 90031-3321
For Additional Information Contact David Somali
Manufacturer Reason
for Recall
Potential for microorganism growth in the alcohol standard.
FDA Determined
Cause 2
Action The firm sent a recall notification to their customer in Indonesia and advised them to dispose of the product
Quantity in Commerce 6 units
Distribution Country of Indonesia
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 = JIX and Original Applicant = VERICHEM LABORATORIES, INC.