Date Initiated by Firm |
December 17, 2003 |
Date Posted |
July 23, 2004 |
Recall Status1 |
Terminated 3 on August 30, 2004 |
Recall Number |
Z-1152-04 |
Recall Event ID |
29096 |
510(K)Number |
k926236
|
Product Classification |
Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
|
Product |
Array Systems Calibrator 5
Part No. 465250 |
Code Information |
Lot M305283 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
Manufacturer Reason for Recall |
The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.
|
FDA Determined Cause 2 |
Other |
Quantity in Commerce |
1000 |
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 = GTQ and Original Applicant = BECKMAN INSTRUMENTS, INC.
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