Open, Classified

DYNEX Agility, Agility Analyzer, Model No. 67000

FDA Recall Z-1222-2022 · Posted None

Recall StatusOpen, Classified

Product CodeLXG

Date Initiated2020-07-05

Product Quantity218 units (17 installed with v1.4.3)

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.