• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Mega Diagnostics Alcohol Standard

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall Mega Diagnostics Alcohol Standard see related information
Date Posted April 14, 2007
Recall Status1 Terminated 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/
Manufacturer
Mega Diagnostics
2716 N Main St
Los Angeles CA 90031-3321
323-221-8088
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
Other
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.
-
-