Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

Reason: Potential for errors in patient results generated by the Specimen Gate Laboratory Software.

Code information: Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

Distribution pattern: Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil