Recall Z-1082-04 ยท JQW Station, Pipetting And Diluting, For Clinical Use
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.
| Date | Jul 20, 2004 (initiated Jun 11, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.