Urgent Field Safety Notice For Aptiva Ctd Essential Reagent By Inova Diagnostics, Inc.

Summary Inova Diagnostics, Inc. is issuing an urgent safety notice for Aptiva CTD Essential Reagent, a diagnostic device reagent distributed in Germany and the EU. The company has classified this as a Class I recall, indicating a serious safety concern. The notice affects users of this reagent in the European market.

Recalling firm
Inova Diagnostics, Inc.
Product
Aptiva CTD Essential Reagent
Reason
Urgent Field Safety Notice for Aptiva CTD Essential Reagent by Inova Diagnostics, Inc.
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-28
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/545f5024-f62f-4c45-bd6b-24ca96d3285c