Mizuho USA, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mizuho USA, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Mizuho USA, Inc. is recalling Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm C due to False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026