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Terminated

OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate.'' Each box contains one home test kit. Responsible firm on label: Distributed by: ICC, Amherst, NY 14228

FDA Recall Z-0453-05 · Posted 2005-01-28

Recalling FirmInternational Chemical Inc.
Recall StatusTerminated
Product CodeLCX
Date Initiated2004-10-07
Date Terminated2005-10-13
Product Quantity108

Reason for Recall

Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.

Firm Action

The consignee (exporter) was notified via telephone in October 2004 regarding lot U040904 (cassette) and notified via telephone regarding the expanded recall (lot U060804, One-Step) on 12/27/2004. A recall letter issued regarding both lots on 1/10/2005.

Root Cause

Other

Distribution Pattern

Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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