FDA recall Z-0441-2021

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-10-06

Report date

2020-11-18

Termination date

2021-05-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Maria, CA, United States

Primary source

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