Recall Z-0557-06 ยท LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Diasorin Inc.
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).
| Date | Feb 23, 2006 (initiated Aug 8, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 22 |
| Distribution | Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991274 | MUMPS IGG ELISA TEST SYSTEM Columbia Bioscience, Inc., Sep 3, 1999 |