Z-1018-2010

Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test

Name: Z-1018-2010 Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test
Creator: Mainline Technology, Inc.
Published: 2009-10-07
License: https://open.fda.gov/license/

Mainline Technology, Inc. / initiated 2009-10-07 / Terminated / root cause: labeling and UDI

FDA source

Mainline Technology, Inc. began a recall of Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test on 2009-10-07. 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 expirations 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-1018-2010
Status: Terminated
Initiated: 2009-10-07
Posted: 2010-03-08
Terminated: 2011-02-04
Recalling firm: Mainline Technology, Inc.
Product: Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
Product code: LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 expirations dates.
Root cause tag: labeling and UDI
FDA root cause: PMA
Action: Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.
Quantity in commerce: Information not provided.
Distribution: Worldwide Distribution -- United States, Belgium and Switzerland.
Product codes and lots: Lot 25310 and 25831.

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)