Recall Z-1715-2008 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Siemens Medical Solutions Diagnostics
In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
| Date | Sep 1, 2008 (initiated Apr 4, 2008) |
| Status | Terminated |
| Reason | False negative hCG results due to decreased sensitivity |
| Root cause | Component design/selection |
| Action | Siemens notified Distributors ( Distributor Bulletin Urgent Field Safety Notice) and end-users (Customer Bulletin Urgent Field Safety Notice) Clinitest hCG Cassette Recall by letter dated 4/3/08. Users are requested to, discontinue use, discard the product, and immediately contact Siemens technical support representative or distributor for replacement cassettes from a different lot. If you have any question or have not received the recall notification, contact your local Siemens Distributor Relations Representative or Siemens Technical Support at 877-229-3711 option 13 then 5. |
| Quantity | 8180 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032563 | CLINITEST HCG PREGNANCY TEST Bayer Healthcare, LLC, Dec 23, 2003 |