FDA-Device2020-12-30Class II
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
Hardy Diagnostics
Hazard
There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
Sold states
US Nationwide Distribution: CA, NC, AK, NY, OH, IL, NC, WI, SD, FL, DE, MI, MA, MD, GA, , TX, PA, IA, WV, ID, UT, KS, OR, CT, NY, WA, VA, TN, HI, AL, KY, MN, PR, MO, WI, AZ, SC, LA, AR, IN, NE, MS, NH, and OK.
Affected count
686,920 devices
Manufactured in
1430 W McCoy Ln, N/A, Santa Maria, CA, United States
Products
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0655-2021Don't want to check this manually?
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