Hardy Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-0441-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 6, 2020

Date Posted: November 18, 2020

Recall Number: Z-0441-2021

Event ID: 86586

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

Status: Terminated

Product Quantity: 8,620 units

Code Information:

Lot # 465086

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

Voluntary or Mandated:

Voluntary: Firm initiated