In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test
FDA device recall Z-1715-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- False negative hCG results due to decreased sensitivity
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 8180
- Distribution
- Nationwide
- Date initiated
- 2008-04-04
- Date posted
- 2008-09-01
- Date terminated
- 2012-03-15
- Location
- Norwood, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITEST HCG PREGNANCY TEST (K032563) | Bayer Healthcare, LLC | 2003-12-23 |