| Date Initiated by Firm | July 22, 2019 |
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| Create Date | September 09, 2019 |
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| Recall Status1 |
Terminated 3 on May 21, 2020 |
| Recall Number | Z-2494-2019 |
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| Recall Event ID |
83426 |
| Product Classification |
unknown device name - Product Code N/A
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| 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 |
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| Code Information |
Software versions: 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 |
| FEI Number |
2242436
|
Recalling Firm/
Manufacturer |
Zeus Scientific, Inc.
199 Evans Way
Branchburg NJ 08876-4600
|
| For Additional Information Contact | SAME
908-526-3744 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Software design |
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| 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. |
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| Quantity in Commerce | 28 Assays |
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| Distribution | US nationwide distribution in the states of CA, CT, FL, KY, IN, MA, MI, NY, NJ, NH, OH, PA, TX, VA. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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