🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 22, 2019 Zeus Scientific Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zeus Scientific, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2494-2019

Related Recalls

ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage: intended for the qualitative detection of IgM class antibodies to human Parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human Parvovirus B19.

Zeus Scientific

Class I - Dangerous

FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm assigned a new Correction Factor and new lot number to the remainder of the affected lot, and distributed the reworked product to the customer.

Aug 12, 2019 Diagnostic Equipment Nationwide View Details →