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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 10, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 16, 2004
Recall NumberZ-1098-04
Recall Event ID 29054
510(K)NumberK011213 K014034 K023049 K965240 
Product Classification unknown device name - Product Code EXEMP
ProductSynchron LX Clinical Systems, Operating Software, All versions.
Code Information All Versions.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.
FDA Determined
Cause 2		Other
Quantity in Commerce816
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) Database510(K)s with Product Code = EXEMP
510(K)s with Product Code = EXEMP
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