Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits,
FDA device recall Z-0469-2007 · posted 2007-01-05 · Terminated
Recall details
- Recalling firm
- Mizuho USA, Inc.
- Reason for recall
- False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
- Action taken
- On November 14, 2006, Mizuho USA and SSL decided to cease further distribution of the product, and to contact SSL''s customers and ask them to return any unsold units. Mizuho USA informed SSL Americas by telephone. On November 21, 2006, SSL Americas sent Recall Notification Letters to each of its customers by US First Class, Certified, Return-receipt mail. The letter included a 'Fax Back' Notification to be use by the firm for recall effectiveness checks.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCX
- Quantity affected
- 474,000 Kits
- Distribution
- Worldwide-USA and Canada
- Date initiated
- 2006-11-17
- Date posted
- 2007-01-05
- Date terminated
- 2008-05-23
- Location
- Poway, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTI-USE ELECTRONIC PREGNANCY TEST (K060825) | Mizuho USA, Inc. | 2006-06-19 |