Dynex Technologies, Inc. Recalls
Showing 1-2 of 2 recalls
DYNEX Agility, Agility Analyzer, Model No. 67000
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.
The firm first notified customers via mail and email between June and July 2020. Although only 17 units had been released with v1.4.3 installed, the firm notified all customers in possession of a device out of an abundance of caution. Customers were given workaround instructions to prevent the problem from occurring while the software was being corrected. Customers then received a follow up Field Safety Notice dated September 29, 2020. Distributors were asked to pass on the notification to any downstream customer accounts. The Agility software was updated to v1.4.7 to prevent controls and calibrators from sharing the same name. The update should prevent recurrence of the issue.
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.
An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.
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.