Date Initiated by Firm | October 10, 2003 |
Date Posted | November 19, 2003 |
Recall Status1 |
Terminated 3 on March 30, 2004 |
Recall Number | Z-0136-04 |
Recall Event ID |
27512 |
Product Classification |
Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
|
Product | Coulter DNA Prep Reagents Kit Part 6607055 |
Code Information |
Lot # 760203k-760208k, 760213k, 760218k |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92821-6208
|
For Additional Information Contact | Kathleen Jaker 714-961-3666 |
Manufacturer Reason for Recall | Labeling Error-Omission of 'Research Use Only' |
FDA Determined Cause 2 | Other |
Action | All customers are to be notified with a product correction action letter. |
Quantity in Commerce | 284 |
Distribution | Nationwide and Canada |
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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