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Terminated

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).

FDA Recall Z-0557-06 · Posted 2006-02-23

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLJY
Date Initiated2005-08-08
Date Terminated2006-07-22
Product Quantity22

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991274MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc. · 1999-09-03

Official Source

View FDA Recall →

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

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