Z-0163-04

ICON 25 hCG Test Kit

Name: Z-0163-04 ICON 25 hCG Test Kit
Creator: Beckman Coulter Inc
Published: 2003-10-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-10-31 / Terminated

FDA source

Beckman Coulter Inc began a recall of ICON 25 hCG Test Kit on 2003-10-31. The reason FDA records is "False negative urine results are being observed at an increasing rate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0163-04
Status: Terminated
Initiated: 2003-10-31
Posted: 2004-07-20
Terminated: 2004-05-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ICON 25 hCG Test Kit
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: False negative urine results are being observed at an increasing rate.
FDA root cause: Other
Action: Firm sent letter to customers on 31 OCT 03 expressing not to use kits and that another lot will be substituted. Destruction of recalled lot is requested.
Quantity in commerce: 9040 kits
Distribution: Nationwide and Canada (limited).
Product codes and lots: Lot hCG030303

Product code JHI

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)