FDAClass IIINovember 18, 2020

Strep B Carrot Broth One-Step recall: Labeling Error

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

Why was Strep B Carrot Broth One-Step recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 465086

Product
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Recalling firm
Hardy Diagnostics
Quantity
8,620 units
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
Recall date
November 18, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls