Date Initiated by Firm |
May 10, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on September 07, 2004 |
Recall Number |
Z-1018-04 |
Recall Event ID |
29165 |
510(K)Number |
k012701
|
Product Classification |
System, Automated Platelet Aggregation - Product Code JOZ
|
Product |
VerifyNow Asprin Assay Kit
Part No. 85034 |
Code Information |
Assay Device Lot WD0034, Kit Lots W17105, W17140. |
Recalling Firm/ Manufacturer |
Accumetrics Inc 3985 B Sorrento Valley Blvd San Diego CA 92121
|
For Additional Information Contact |
Roberta Hoffman 888-919-9333 Ext. 218
|
Manufacturer Reason for Recall |
Test results too low in control.
|
FDA Determined Cause 2 |
Other |
Action |
Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials. |
Quantity in Commerce |
4500 |
Distribution |
Nationwide. |
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 = JOZ and Original Applicant = ACCUMETRICS, INC.
|