Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Numb
FDA device recall Z-1475-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- False positive hCG results
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 3065 kits
- Distribution
- Nationwide Canada, France, Korea, Netherlands, UK
- Date initiated
- 2007-10-17
- Date posted
- 2008-09-01
- Date terminated
- 2012-03-15
- Location
- Norwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.