FDA Medical Device Recalls (openFDA)
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 number
- Z-0453-05
- Recalling firm
- International Chemical Inc.
- 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
- Status
- Terminated
- Initiated
- 2004-10-07
- Posted
- 2005-01-28
- Terminated
- 2005-10-13
- Reason
- Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
- Root cause
- Other
- 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.
- Quantity
- 108
- Distribution
- Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean.
- Lot, serial or model codes
- U040904, Exp. 30SEP06; UPC code: 310960 451003
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LCX
- Firm FEI
- 1319423
- Firm city
- Amherst
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28