FDA-Device2025-01-29Class II
BD PCR Cartridges used with MAX System. Model Number: 437519
Becton Dickinson & Co.
Hazard
Potential for signal drift in specific lots of BD PCR Cartridges.
Sold states
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.
Affected count
516,435 units
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
BD PCR Cartridges used with MAX System. Model Number: 437519
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2025Don't want to check this manually?
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