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

Recall Summary Inova Diagnostics is recalling Aptiva CTD Essential Reagent, a diagnostic test reagent distributed in Germany and the EU, due to an urgent safety issue. This is a Class I recall, indicating a serious problem with the product. The recall affects medical facilities and laboratories that use this reagent for diagnostic testing.

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/5740e5ee-049e-45bd-9043-81fbdab9eb2a