FDA-Device2016-10-05Class II
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.
Trividia Health
Hazard
Product gives incorrect low blood glucose levels.
Sold states
Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.
Affected count
5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally
Manufactured in
2400 NW 55th Ct, N/A, Fort Lauderdale, FL, United States
Products
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2881-2016Don't want to check this manually?
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