West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes W
FDA device recall Z-0182-2013 · posted 2012-10-31 · Terminated
Recall details
- Recalling firm
- Focus Diagnostics Inc
- Reason for recall
- The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
- Action taken
- Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NOP
- Quantity affected
- 425 units
- Distribution
- Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
- Date initiated
- 2012-10-03
- Date posted
- 2012-10-31
- Date terminated
- 2012-12-04
- Location
- Cypress, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WEST NILE VIRUS ELISA IGG, MODEL EL0300G (K031953) | Focus Technologies, Inc. | 2003-10-22 |