Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips pe
FDA device recall Z-1082-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Dynex Technologies, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQW
- Quantity affected
- 1749 cartons
- Distribution
- Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.
- Date initiated
- 2004-06-11
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-18
- Location
- Chantilly, VA
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