FDA Medical Device Recalls (openFDA)
Dynex Technologies, Inc.: 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.
- Recall number
- Z-1082-04
- Recalling firm
- Dynex Technologies, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2004-06-11
- Posted
- 2004-07-20
- Terminated
- 2004-08-18
- Reason
- An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.
- Root cause
- Other
- Action
- 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.
- Quantity
- 1749 cartons
- Distribution
- Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.
- Lot, serial or model codes
- Lot 412410 printed on carton
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQW
- Firm FEI
- 1117676
- Firm city
- Chantilly
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28