Device Recall EVOLIS Assay Protocol Files ( APF) Software

APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2

Immunology and Microbiology Devices

2

No

Nationwide Distribution -- Including Puerto Rico.

Software CD is labeled in part: || "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" || The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.