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Recall Observatory FDA recall evidence

Device product

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

Z-0441-2021

October 06, 2020

Class III

Product summary

Firm
Hardy Diagnostics
Event
Event 86586
Status
Terminated
Classification
Class III
Quantity
8,620 units
Official record key
device-enforcement:Z-0441-2021

Official wording

Reason: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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