FDA Medical Device Recalls (openFDA)
Mainline Technology, Inc.: Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
- Recall number
- Z-1018-2010
- Recalling firm
- Mainline Technology, Inc.
- Product
- Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
- Status
- Terminated
- Initiated
- 2009-10-07
- Posted
- 2010-03-08
- Terminated
- 2011-02-04
- Reason
- 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
- 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
- Information not provided.
- Distribution
- Worldwide Distribution -- United States, Belgium and Switzerland.
- Lot, serial or model codes
- Lot 25310 and 25831.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LCX
- Firm FEI
- 1000160426
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28