Urgent Field Safety Notice For Anti-annexin V Igg By Orgentec Diagnostika Gmbh
Recall Summary Orgentec Diagnostika GmbH is recalling Anti-Annexin V IgG diagnostic test kits in Germany and the EU due to a safety concern serious enough to warrant urgent notification. The specific reason for the safety issue is not detailed in the available information. This is a Class I recall, indicating the most serious level of regulatory action.
- Recalling firm
- Orgentec Diagnostika GmbH
- Product
- Anti-Annexin V IgG
- Reason
- Urgent Field Safety Notice for Anti-Annexin V IgG by Orgentec Diagnostika GmbH
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-09-04
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/8bba8feb-1e70-49d3-bd79-9d20bab4d9a3