Urgent Field Safety Notice For Anti-spermatozoa Antibody (asa) Serum Elisa By Demeditec Diagnostics Gmbh

Summary Demeditec Diagnostics GmbH is issuing an urgent recall for Anti-Spermatozoa Antibody (ASA) serum ELISA test kits due to a safety concern. The product is used to detect antibodies in blood samples and was distributed in Germany and the EU. This is classified as a Class I recall, which is the most serious type.

Recalling firm
Demeditec Diagnostics GmbH
Product
Anti-Spermatozoa Antibody (ASA) serum ELISA
Reason
Urgent Field Safety Notice for Anti-Spermatozoa Antibody (ASA) serum ELISA by Demeditec Diagnostics GmbH
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-07-16
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/4fa54853-f6ca-40f1-b7f0-4bb9c8ffb4bf