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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 Device Recall Mega Diagnostics Ammonia/Alcohol Controls 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-0743-2007
Recall Event ID 37254
510(K)Number K972333  
Product Classification Ammonia/Alcohol Controls - Product Code JIX
Product Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
Code Information Lot# 522202
Recalling Firm/
Manufacturer		 Mega Diagnostics
2716 N Main St
Los Angeles CA 90031-3321
For Additional Information Contact David Somali
323-221-8088
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		 Other
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 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.
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