Recall Z-0469-2007
Mizuho USA, Inc. · initiated November 17, 2006
Product
Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.
Codes / lots: Confirm Clearly Starter Kits UPC Code 3-02340-30136-7 and Confirm Clearly Refills Kit UPC Code 3-02340-30138-1 (all lots including: Confirm Clearly Starter Kits Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611 Confirm Clearly Refills Kits Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610 Special Pack Deal (6 Starter Kits & 6 Refill Kits) Lot number; LH608
Reason for recall
False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0469-2007
- Initiated
- November 17, 2006
- Posted by FDA
- January 5, 2007
- Terminated
- May 23, 2008
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Quantity
- 474,000 Kits
- Distribution
- Worldwide-USA and Canada
- Recalling firm
- Mizuho USA, Inc., Poway, CA