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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter

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 Class 2 Device Recall Beckman Coultersee related information
Date Initiated by FirmOctober 10, 2003
Date PostedNovember 19, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall NumberZ-0136-04
Recall Event ID 27512
Product Classification Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
ProductCoulter DNA Prep Reagents Kit Part 6607055
Code Information Lot # 760203k-760208k, 760213k, 760218k
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Labeling Error-Omission of 'Research Use Only'
FDA Determined
Cause 2		Other
ActionAll customers are to be notified with a product correction action letter.
Quantity in Commerce284
DistributionNationwide and Canada
Total Product Life CycleTPLC 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.
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