# FDA recall Z-2494-2019

> **Zeus Scientific, Inc.** · Class II · device recall initiated 2019-07-22.

## 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 Sm-RNP [CF] .asy  ZEUS vl Sm-RNP [CV].asy  ZEUS vl CMV lgG.asy  ZEUS vl CMV lgM.asy  ZEUS vl EBV-VCA lgG.asy  ZEUS vl EBV-VCA lgM.asy  ZEUS vl H. pylori lgG.asy  ZEUS vl M. pneumoniae lgG.asy  ZEUS vl M. pneumoniae lgM.asy  ZEUS vl Measles lgG.asy  ZEUS vl Mumps lgG .asy  ZEUS vl T. gondii lgG .asy  ZEUS vl T. gondii lgM.asy  ZEUS vl VZV lgG.asy  ZEUS vl Rubella lgG .asy  ZEUS vl Rubella lgM.asy  ZEUS vl MPO [CF].asy  ZEUS vl MPO [CV].asy  ZEUS vl EBNA-1 lgG.asy  ZEUS vl.1 HSV-1 and 2 lgM.asy   Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

## Reason for recall

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.

## Distribution

US nationwide distribution in the states of CA, CT, FL, KY, IN, MA, MI, NY, NJ, NH, OH, PA, TX, VA.

## Key facts

- **Recall number:** Z-2494-2019
- **Recalling firm:** Zeus Scientific, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-22
- **Report date:** 2019-09-18
- **Termination date:** 2020-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2494-2019

## Citation

> AI Analytics. FDA recall Z-2494-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2494-2019. Source: US FDA. Licensed CC0.

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