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

Recall Summary Demeditec Diagnostics GmbH is recalling Anti-Spermatozoa Antibody (ASA) serum ELISA test kits distributed in Germany and the EU due to an unspecified safety issue. This is a Class I recall, the most serious classification. The recall affects laboratories and healthcare facilities using this diagnostic test.

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
2026-07-20
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/67db7639-9813-45c1-8eb1-d62f7bb6ab85