Device Recall Getinge Assure Accufast BI Test Pack w/ 25 Controls

Affected Biological Indicator Lot No.:121101-447 and 121101-444

General Hospital and Personal Use Devices

2

No

Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 || The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.