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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 FirmJune 11, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 18, 2004
Recall NumberZ-1082-04
Recall Event ID 29421
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
ProductPipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.
Code Information Lot 412410 printed on carton
FEI Number 1117676
Recalling Firm/
Manufacturer		 Dynex Technologies, Inc.
14340 Sullyfield Cir
Chantilly VA 20151-1621
For Additional Information ContactJohn McCrea
703-631-7800 Ext. 1245
Manufacturer Reason
for Recall		An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified consignees by faxed letter on 6/11/04 and follow-up letter by mail 6/24/04. The notice advised of vacuum failure associated with lot 412410 of sample tips and recommended quarantine of the defective tips. Consignees were requested to return response form. The 6/24/04 notification recommends that consignees discard/destroy lot 412410 and asks distributors to notify their customers. The firm is working with supplier of the pipette tips to replace recalled product.
Quantity in Commerce1749 cartons
DistributionPipette tips were sold to seven OEMs for distribution to end users in the US and internationally.
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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