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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxC Synchron Clinical Systems

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 Class 2 Device Recall UniCel DxC Synchron Clinical Systemssee related information
Date Initiated by FirmMay 15, 2006
Date PostedAugust 26, 2006
Recall Status1 Terminated 3 on April 08, 2013
Recall NumberZ-1440-06
Recall Event ID 35646
Product Classification Chemistry Analyzer - Product Code NDW
ProductUniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Code Information Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNora Zerounian
714-961-3634
Manufacturer Reason
for Recall		Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results.
FDA Determined
Cause 2		Other
ActionA Product Correction Action (PCA) letter was sent the week of May 15, 2006 to all Unicel DxC customers informing them not to leave any Lithium reagent cartridge onboard a UniCel DxC System past 14 days. They also were instructed to complete and return the enclosed response form. The Letter was sent by US Mail.
Quantity in Commerce524
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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