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.
|