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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJune 19, 2003
Date PostedAugust 06, 2003
Recall Status1 Terminated 3 on December 01, 2004
Recall NumberZ-1077-03
Recall Event ID 26722
ProductSynchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178
Code Information No range of serial numbers apply.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactKathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
FDA Determined
Cause 2		Other
ActionA revised template with a recall letter was sent to customers with a response request on 19 June 2003.
Quantity in Commerce502
DistributionUSA and Canada.
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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