DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
FDA device recall Z-1478-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
- Action taken
- Recall was initiated on 3/1/2010. DiaSorin S.R.I. (the sole consignee) was alerted via email using the firm's Medical Device Recall Notification. Consignee informed of the recall and instructed to dispose of the affected product according to local laws.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKJ
- Quantity affected
- 999 kits
- Distribution
- Foreign Only: One distributor, DiaSorin S.R.I. in Italy. No wholesalers. No retailers. No domestic distribution, No Federal Government sales/distribution centers.
- Date initiated
- 2010-03-01
- Date posted
- 2011-03-02
- Date terminated
- 2011-03-11
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723) | Helix Diagnostics, Inc. | 1995-12-15 |