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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens Medical Solutions Diagnostics
Lot Codes / Batch Numbers
Lot 97552 Exp 05/16/08, Lot 97574 Exp 05/17/08
Products Sold
Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08
Siemens Medical Solutions Diagnostics is recalling In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gon due to False negative hCG results due to decreased sensitivity. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False negative hCG results due to decreased sensitivity
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026