Z-0557-06

The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to...

Name: Z-0557-06 The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to...
Creator: Diasorin Inc.
Published: 2005-08-08
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2005-08-08 / Terminated / root cause: software

FDA source

Diasorin Inc. began a recall of The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated... on 2005-08-08. The reason FDA records is "Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0557-06
Status: Terminated
Initiated: 2005-08-08
Posted: 2006-02-23
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).
Product code: LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Reason for recall: Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG.
Root cause tag: software
FDA root cause: Other
Action: Consignees were contacted by telephone and then the firm sent a fax titled 'Diasorin Customer Notification' dated 8/8/05 that documented the information as provided by telephone.
Quantity in commerce: 22
Distribution: Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
Product codes and lots: ETI-Mumps Assay software version 1.0

Product code LJY

K991274Class IMumps Igg Elisa Test SystemColumbia Bioscience, Inc. / cleared 1999-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)