Z-1082-04

Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108...

Name: Z-1082-04 Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108...
Creator: Dynex Technologies, Inc.
Published: 2004-06-11
License: https://open.fda.gov/license/

Dynex Technologies, Inc. / initiated 2004-06-11 / Terminated

FDA source

Dynex Technologies, Inc. began a recall of Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory... on 2004-06-11. The reason FDA records is "An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1082-04
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-07-20
Terminated: 2004-08-18
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.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
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 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 in commerce: 1749 cartons
Distribution: Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.
Product codes and lots: Lot 412410 printed on carton

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)