International Chemical Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
International Chemical Inc.
Lot Codes / Batch Numbers
U040904, Exp. 30SEP06, UPC code: 310960 451003
Products Sold
U040904, Exp. 30SEP06; UPC code: 310960 451003
International Chemical Inc. is recalling OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and due to Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
FL, IN
Page updated: Jan 10, 2026