Z-0706-03

ICON DS hCG, an in-vitro diagnostic. Part number 44025

Name: Z-0706-03 ICON DS hCG, an in-vitro diagnostic. Part number 44025
Creator: Beckman Coulter Inc
Published: 2003-02-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-02-20 / Terminated

FDA source

Beckman Coulter Inc began a recall of ICON DS hCG, an in-vitro diagnostic. Part number 44025 on 2003-02-20. The reason FDA records is "Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0706-03
Status: Terminated
Initiated: 2003-02-20
Posted: 2003-04-02
Terminated: 2003-09-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ICON DS hCG, an in-vitro diagnostic. Part number 44025.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
FDA root cause: Other
Action: Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.
Quantity in commerce: 12,804
Distribution: Nationwide and Canada.
Product codes and lots: Lot numbers hCG010401, hCG010704, hCG010902

Product code JHI

K993203Class IIAcon One Step Pregnancy Test Strip (Urine)ACON Laboratories, Inc. / cleared 1999-12-01

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)