DYNEX Agility, Agility Analyzer, Model No. 67000
Reported: June 8, 2022 Initiated: July 5, 2020 #Z-1222-2022
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.
Details
- Recalling Firm
- Dynex Technologies, Inc.
- Units Affected
- 218 units (17 installed with v1.4.3)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY, OH, PA, PR, TN, TX, UT, VA, WI, WV and the countries of Belgium, Brazil, China, Czech Republic, France, Germany, Mexico, Qatar, Romania, Russia, South Korea, Switzerland, Taiwan, and UK.
- Location
- Chantilly, VA
Frequently Asked Questions
What product was recalled? ▼
DYNEX Agility, Agility Analyzer, Model No. 67000. Recalled by Dynex Technologies, Inc.. Units affected: 218 units (17 installed with v1.4.3).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1222-2022.
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