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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 23, 2003
Date Posted July 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1154-04
Recall Event ID 29101
Product Power Processor Aliquot Tube Labels
Part 800255
Code Information Lots 21045673; 2105246; 21361906.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		 Labels are missing an expiration date and storage instructions, increasing the likelihood that they will not be used by the expiration date or may be stored under conditions that would cause adhesive failure and loss of identity of sample or aliquot during testing.
FDA Determined
Cause 2		 Other
Quantity in Commerce 170 rolls
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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