Reported Jun 8, 2022 · Ongoing
DYNEX Agility, Agility Analyzer, Model No. 67000
Dynex Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dynex Technologies, Inc. · 14340 Sullyfield Cir · Chantilly, VA · 20151-1621
Is this the product you have?
- DYNEX Agility, Agility Analyzer, Model No. 67000
- Lot codes and dates
- UDI-DI05060456180058 Software version v1.4.3
- Serial numbers
218 of 218 codes
1GXA00211GXA00221GXA00231GXA00241GXA00251GXA00261GXA00271GXA00281GXA00291GXA00301GXA00311GXA00321GXA00331GXA00341GXA00351GXA00361GXA00371GXA00381GXA00391GXA00401GXA00411GXA00421GXA00431GXA00441GXA00451GXA00461GXA00471GXA00481GXA00491GXA00501GXA00511GXA00521GXA00531GXA00541GXA00551GXA00561GXA00571GXA00581GXA00591GXA00601GXA00611GXA00621GXA00631GXA00641GXA00651GXA00661GXA00671GXA00681GXA00691GXA00701GXA00711GXA00721GXA00731GXA00741GXA00751GXA00761GXA00771GXA00781GXA00791GXA0080
- Amount recalled
- 218 units (17 installed with v1.4.3)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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