Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Category
- Medical Device
- Distribution
- Distributed nationwide