Dynex recalls Agility Analyzer Model 67000 software v1.4.3 due to risk of using incorrect control samples, which may delay patient results. Affected units have specific serial numbers.
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.
Dynex is recalling its Agility Analyzer Model 67000 with software version 1.4.3 because it can use the wrong control samples from another assay, potentially delaying patient results. This affects laboratory equipment used for medical testing.
The software version 1.4.3 has a bug that causes the system to aspirate control samples from the wrong SmartKit. This means the lab might use a control sample intended for another assay instead of the correct one, which could lead to delayed patient results if the test is not properly validated.
Laboratories using the Dynex Agility Analyzer Model 67000 with software version 1.4.3 are most at risk. This primarily impacts medical testing facilities that rely on this equipment for accurate patient results.
Check if your Agility Analyzer has serial numbers starting with 1GXA0021 through 1GXA0217 or 1GXAB001 through 1GXAB020. The software version should be v1.4.3 to be affected.
Install software version 1.4.7 to fix the issue, as the manufacturer has released an update.
The software version 1.4.3 has a bug that causes the system to use the wrong control samples from another assay, which may delay patient results.
Check if your Agility Analyzer has serial numbers starting with 1GXA0021 through 1GXA0217 or 1GXAB001 through 1GXAB020 and software version 1.4.3.
Update to software version 1.4.7 to resolve the issue. The manufacturer has released this update to fix the problem.
We’ve drafted a message you can send Dynex to request your refund or repair — edit it as you like.
Subject: Recall Z-1222-2022 — Dynex Dynex Hello, I own a Dynex that is covered by recall Z-1222-2022 from Dynex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
