Zeus Scientific Recalls Dynex DSX Software for False Negative ELISA Results
Zeus Scientific is recalling 28 Dynex DSX software files due to a programming error that causes false negative results in specific ELISA assays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software error that can lead to false negative diagnostic results, which is a risk-of-harm scenario where injury or adverse health consequences have not yet been reported.
Plain-English summary
Zeus Scientific, Inc. is recalling 28 Dynex DSX Software-IVD ELISA Assay files used on the open Dynex DSX Instrument. The recall affects specific software versions used to process In Vitro Diagnostic (IVD) ELISA samples for various antibodies, including those for B. burgdorferi, Parvovirus B19, HSV-1 and 2, and others.
The recall is due to a programming error that causes the instrument to skip the addition of the TMB substrate in well H6. This error results in a negative reading for well H6 regardless of the patient's actual antibody status, potentially leading to false negative results for patients tested in that specific well.
The affected software was distributed nationwide in the states of CA, CT, FL, KY, IN, MA, MI, NY, NJ, NH, OH, PA, TX, and VA. Users of the Dynex DSX Automated ELISA System should stop using the affected software files and contact Zeus Scientific for instructions on how to proceed.
The recalled product
- Product
- Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl S
- Manufacturer
- Zeus Scientific, Inc.
- Affected units
- 28
Distribution
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