Z-0441-2021 Class III Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
November 18, 2020
Initiation Date
October 6, 2020
Termination Date
May 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,620 units

Product Description

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 Pattern

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

Code Information

Lot # 465086