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).
This recall has been terminated (originally issued February 23, 2006).
- Company
- Diasorin Inc.
- Recall Initiated
- August 8, 2005
- Posted
- February 23, 2006
- Terminated
- July 22, 2006
- Recall Number
- Z-0557-06
- Quantity
- 22
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
Lot / Code Info
ETI-Mumps Assay software version 1.0
Root Cause
Other
Action Taken
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.
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