Z-0530-2009

f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065

Name: Z-0530-2009 f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065
Creator: Mainline Technology, Inc.
Published: 2008-08-18
License: https://open.fda.gov/license/

Mainline Technology, Inc. / initiated 2008-08-18 / Terminated / root cause: labeling and UDI

FDA source

Mainline Technology, Inc. began a recall of f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065 on 2008-08-18. The reason FDA records is "Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0530-2009
Status: Terminated
Initiated: 2008-08-18
Posted: 2009-01-15
Terminated: 2011-02-07
Recalling firm: Mainline Technology, Inc.
Product: f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
Root cause tag: labeling and UDI
FDA root cause: PMA
Action: Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.
Quantity in commerce: 52 kits
Distribution: Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
Product codes and lots: Lot 20087.

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)