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.
FDA Recall Z-0469-2007 · Posted 2007-01-05
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Recalling FirmMizuho USA, Inc.
Recall StatusTerminated
Product CodeLCX
Date Initiated2006-11-17
Date Terminated2008-05-23
Product Quantity474,000 Kits
Reason for Recall
False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide-USA and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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