BD MAX SYSTEM

Catalog number 441916

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.

Software version 4.44A utilized on the BD MAX System

Catalog No.: 441916 Multiple serial numbers of the affected device are provided in the attached FSN. ................................................................. FDA update codes: BD Max Instrument, Catalog Number 441916 441927 Serial Numbers: CTI1201-CTI1288 Catalog Number 8090369/443364, 44336409 Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927

IVD Test Reagent/Kits

Medical Device Safety Alert: BD MAX System Software Version 4.44A

Model Catalog: 441916 (Lot serial: CM0006); Model Catalog: 441916 (Lot serial: CM0094)

BD MAX Instrument

Model Catalog: 441916 (Lot serial: N/A)

BD MAX SYSTEM SOFTWARE V4.44A