Recall Z-1475-2008 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Siemens Medical Solutions Diagnostics
Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
| Date | Sep 1, 2008 (initiated Oct 17, 2007) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.