Zeus Scientific recalls specific Dynex DSX software for false negative results in Lyme disease tests due to a programming error skipping well H6. Affected users should check their software versions and contact support.
Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.
Zeus Scientific recalls certain Dynex DSX software versions that may produce false negative results for Lyme disease tests. This could lead to incorrect conclusions about whether a patient has the infection, which is serious for accurate diagnosis.
The software has a programming error that skips well H6 during testing. This causes the system to report a negative result regardless of whether the patient was actually positive or negative for Lyme disease antibodies, potentially leading to missed diagnoses.
Users of the Dynex DSX Automated ELISA System with the specific software versions listed in the recall. Laboratory staff and healthcare providers testing for Lyme disease are most at risk.
Check if your Dynex DSX software includes the listed file names such as 'ZEUS vl B. burgdorferi lgG-lgM.asy' or similar. The software was sold with the Dynex DSX Automated ELISA System for laboratory use.
Review your Dynex DSX software files to see if they match the listed versions in the recall notice.
The affected software versions include ZEUS vl B. burgdorferi lgG-lgM.asy, ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy, and several other specific file names listed in the recall.
The error causes well H6 to be skipped during testing, resulting in a false negative result for Lyme disease tests regardless of the patient's actual antibody status.
Yes, you should check your software versions against the list provided in the recall. If affected, contact Zeus Scientific for further instructions.
We’ve drafted a message you can send Zeus Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2494-2019 — Zeus Scientific Zeus Scientific Hello, I own a Zeus Scientific that is covered by recall Z-2494-2019 from Zeus Scientific. 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.
