ELISA sample tip racks recalled over internal label misidentifying tip type
Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The only consequence stated is a delay in obtaining patient results rather than erroneous results or patient harm, which places this at rubric level 2.
Plain-English summary
Dynex Agility Sample Tips, model number 67910, UDI-DI 5060456180072, lot number 863366, are being recalled. The tips are an accessory and consumable used with the Agility Automated ELISA system. The recall covers 237 units distributed in California, Florida, North Carolina, New Jersey and New York.
The internal label affixed to the sample tip rack is incorrectly labeled as a reagent tip rack. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use, which causes a delay in obtaining patient results. The FDA classified the action as Class II.
Laboratories holding this lot should follow the manufacturer's instructions for replacement stock.
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.
- Affected units
- 237
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
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