FDA-Device2019-03-06Class II
Phoenix AST-s Indicator, Catalog Number 246009
Becton Dickinson & Co.
Hazard
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Sold states
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam
Affected count
62880 total
Manufactured in
7 Loveton Cir, Sparks, MD, United States
Products
Phoenix AST-s Indicator, Catalog Number 246009
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2019Don't want to check this manually?
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