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U.S. Department of Health and Human Services

Class 3 Device Recall Mega Diagnostics Ammonia/Alcohol Controls

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 Class 3 Recall
Mega Diagnostics Ammonia/Alcohol Controls
see related information
Date Posted April 14, 2007
Recall Status1 Open
Recall Number Z-0743-2007
Recall Event ID 37254
Premarket Notification
510(K) Numbers
K882117  K972333 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
Code Information Lot# 522202
Recalling Firm/
Mega Diagnostics
2716 N Main St
Los Angeles, California 90031-3321
For Additional Information Contact David Somali
Manufacturer Reason
for Recall
Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.
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 12 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.