Pipette 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.
- Company
- Dynex Technologies, Inc.
- Recall Initiated
- June 11, 2004
- Posted
- July 20, 2004
- Terminated
- August 18, 2004
- Recall Number
- Z-1082-04
- Quantity
- 1749 cartons
- Firm Location
- Chantilly, VA
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.
Distribution
Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.
Lot / Code Info
Lot 412410 printed on carton
Root Cause
Other
Action Taken
The 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.