FDA Medical Device Recalls (openFDA)
Mainline Technology, Inc.: Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
- Recall number
- Z-0531-2009
- Recalling firm
- Mainline Technology, Inc.
- Product
- Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
- Status
- Terminated
- Initiated
- 2008-08-18
- Posted
- 2009-01-15
- Terminated
- 2011-02-07
- 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 expiration dates.
- 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
- 33919 kits
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
- Lot, serial or model codes
- Lots 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060, 21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703, 23994, 24483, and 25080.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JHI
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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