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Terminated

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

FDA Recall Z-2494-2019 · Posted None

Recalling FirmZeus Scientific, Inc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2019-07-22
Date Terminated2020-05-21
Product Quantity28 Assays

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.

Firm Action

ZEUS Scientific issued notification on 7/22/19 via E-mail and Fed Ex with copies of the Correction Letter. ZEUS Scientific has instructed the customers to immediately stop use of the installed files and to uninstall the affected files.The customers were informed that if any additional help is required with this request, ZEUS Scientific Technical Service can assist with the deletion either by phone, e-mail or an onsite visit. ZEUS Scientific is working with Dynex to trace each assay at the customer site to see if any patient samples were run on the affected well HG. Once completed, ZEUS Scientific has requested that the laboratories e-mail or fax back a copy of the acknowledgement form included in the Correction Letter stating that they have stopped use of the files and have uninstalled them.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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