FDA-Device2020-11-18Class III

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Hardy Diagnostics
Hazard

Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

Sold states
US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam
Affected count
8,620 units
Manufactured in
1430 W McCoy Ln, Santa Maria, CA, United States
Products
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2021

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