Date Initiated by Firm |
December 04, 2009 |
Date Posted |
April 06, 2010 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number |
Z-1233-2010 |
Recall Event ID |
54279 |
510(K)Number |
K040273
|
Product Classification |
Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
|
Product |
Envoy 500 Serum Control Kit.
The device is used for monitoring the performance of clinical chemistry methods within the clinical range. |
Code Information |
Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010. |
Recalling Firm/ Manufacturer |
Vital Diagnostics, Inc. 27 Wellington Rd Lincoln RI 02865-4411
|
For Additional Information Contact |
401-642-8400
|
Manufacturer Reason for Recall |
Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means.
The ranges were adjusted to reflect the analyzer population.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822. |
Quantity in Commerce |
871 Kits |
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 = JJY and Original Applicant = BIO-RAD LABORATORIES, INC.
|