FDA Device

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.

Hazard

An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.

What You Should Do

Remedy

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.

Products

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
Brand
Dynex Technologies, Inc.
UPC
Lot 412410 printed on carton

Units Affected

1749 cartons