Z-0469-2007

Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly...

Name: Z-0469-2007 Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly...
Creator: Mizuho USA, Inc.
Published: 2006-11-17
License: https://open.fda.gov/license/

Mizuho USA, Inc. / initiated 2006-11-17 / Terminated

FDA source

Mizuho USA, Inc. began a recall of Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) Note: (1) Confirm... on 2006-11-17. The reason FDA records is "False positives-the firm has received a higher than expected rate of complaints regarding false-positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0469-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2007-01-05
Terminated: 2008-05-23
Recalling firm: Mizuho USA, Inc.
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.
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
FDA root cause: Other
Action: 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.
Quantity in commerce: 474,000 Kits
Distribution: Worldwide-USA and Canada
Product codes and 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

Product code LCX

K060825Class IIMulti-Use Electronic Pregnancy TestMizuho USA, Inc. / cleared 2006-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)