Date Initiated by Firm | September 20, 2006 |
Date Posted | April 14, 2007 |
Recall Status1 |
Terminated 3 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
|
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JIX
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