Recall Z-1222-2022— Dynex Technologies, Inc.
Class II · Ongoing
Class II FDA medical device recall by Dynex Technologies, Inc., initiated 2020-07-05. FDA's recall record names no specific 510(k) clearance for this event. Product: DYNEX Agility, Agility Analyzer, Model No. 67000. Reason: 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..
- Recalling firm
- Dynex Technologies, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-07-05
- Firm location
- Chantilly, VA, United States
Product description
DYNEX Agility, Agility Analyzer, Model No. 67000
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.