Dynex Agility Sample Tips Misidentified Due to Incorrect Internal Labeling
Dynex Agility Sample Tips (Model 67910) have incorrect internal labeling that causes the instrument to misidentify them as a different tip type. This incompatibility prevents use and delays patient test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a labeling error that causes device incompatibility and operational failure, but with no reported safety hazard, injuries, or illnesses. The consequence is diagnostic delay rather than patient harm.
Plain-English summary
Dynex Technologies is recalling Agility Sample Tips, Model 67910 (237 units) distributed domestically in California, Florida, North Carolina, New Jersey, and New York. These tips are consumables used with the Dynex Agility Automated ELISA system.
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tips are misidentified as a different tip type.
This labeling error renders the tips incompatible with the system and prevents their use, which causes delays in obtaining patient results. Healthcare facilities in the affected states that have received affected lot 863366 should contact Dynex Technologies or refer to the official FDA recall notice for guidance on replacement or further instructions.
The recalled product
- Product
- Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
- Manufacturer
- Dynex Technologies, Inc.
- Category
- Medical Device
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 67910
- UDI-DI: 5060456180072
- Lot Number: 863366
Distribution
Distributed in 5 states:
- CA
- FL
- NC
- NJ
- NY
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