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.
Recall
- Recall Number
- Z-1715-2008
- Event Number
- 47384
- Firm
- Siemens Medical Solutions Diagnostics
- FEI Number
- 3002637618
- Product Code
- JHI
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 4, 2008
- Posted
- September 1, 2008
- Terminated
- March 15, 2012
- Address
- 2 Edgewater Dr, Norwood, MA, 02062-4637
Description
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.
False negative hCG results due to decreased sensitivity
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.
Nationwide
8180