The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusiv
FDA device recall Z-0557-06 · posted 2006-02-23 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJY
- Quantity affected
- 22
- Distribution
- Nationwide. AK, CA, CT, DC, KS, MA, NY, NJ, PA, SD, TN, TX.
- Date initiated
- 2005-08-08
- Date posted
- 2006-02-23
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUMPS IGG ELISA TEST SYSTEM (K991274) | Columbia Bioscience, Inc. | 1999-09-03 |