FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions Diagnostics: Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
- Recall number
- Z-1475-2008
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Product
- Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
- Status
- Terminated
- Initiated
- 2007-10-17
- Posted
- 2008-09-01
- Terminated
- 2012-03-15
- Reason
- False positive hCG results
- Root cause
- Employee error
- Action
- Siemens issued a Service Bulletin to Siemens Healthcare Diagnostics Branches via email on 10/17/007, and a customer bulletin to outside the US . Users are requested to discontinue use and discard the product. A Completion Notification was requested to be completed and returned by the faculties.
- Quantity
- 3065 kits
- Distribution
- Nationwide Canada, France, Korea, Netherlands, UK
- Lot, serial or model codes
- Lot Number: 97266 Exp. March 12, 2008
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JHI
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- 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