Z-0453-05

OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper...

Name: Z-0453-05 OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper...
Creator: International Chemical Inc.
Published: 2004-10-07
License: https://open.fda.gov/license/

International Chemical Inc. / initiated 2004-10-07 / Terminated / root cause: packaging

FDA source

International Chemical Inc. began a recall of OTC Pregnancy Test Kit labeled: ''CHOICE Pregnancy Test Kit'' (PA-320) , cassette type with cup and dropper. Label states: ''Easy to Use, Easy Reading... on 2004-10-07. The reason FDA records is "Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0453-05
Status: Terminated
Initiated: 2004-10-07
Posted: 2005-01-28
Terminated: 2005-10-13
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
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Reason for recall: Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
Root cause tag: packaging
FDA 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 in commerce: 108
Distribution: Product was shipped to an exporter in Florida who further distributed to consignees in the Caribbean.
Product codes and lots: U040904, Exp. 30SEP06; UPC code: 310960 451003

Product code LCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)