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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 Recall
Mega Diagnostics Alcohol Standard
see related information
Date Posted April 14, 2007
Recall Status1 Open
Recall Number Z-0744-2007
Recall Event ID 37254
Premarket Notification
510(K) Numbers
K882117  K972333 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.
Code Information Lot# 509102
Recalling Firm/
Manufacturer
Mega Diagnostics
2716 N Main St
Los Angeles, California 90031-3321
For Additional Information Contact David Somali
323-221-8088
Manufacturer Reason
for Recall
Potential for microorganism growth in the alcohol standard.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = VERICHEM LABORATORIES, INC.
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