Lower risk Medical device recall · FDA · Published October 6, 2020

Hardy Diagnostics Strep B Carrot Broth One-Step: Incorrect Expiration Date

Hardy Diagnostics recalls Strep B Carrot Broth One-Step (Ref. Z40) due to incorrect expiration date on culture medium packaging. The label shows 2021-11-10 instead of the correct 2020-11-10. Consumers should check their product's expiration date and contact Hardy Diagnostics for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0441-2021Medical device Hardy Diagnostics ›

Lower-risk 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

Take action

Contact the company

Recalling firmHardy Diagnostics1430 W McCoy Ln · Santa Maria, CA 93455-1005

✎ GovInfoNow plain-language explainer

Hardy Diagnostics is recalling Strep B Carrot Broth One-Step (Ref. Z40) because the expiration date on the packaging is incorrect. This could lead to using expired culture medium, which might not be reliable for testing. The recall affects products sold with UDI 00819398026499 and Lot # 465086. Read more at govinfonow.com/recall/64115-hardy-diagnostics-strep-b-carrot-broth-one-step-incorrect-expiration.

Source Summary by GovInfoNow · govinfonow.com/recall/64115-hardy-diagnostics-strep-b-carrot-broth-one-step-incorrect-expiration · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0441-2021

Cite this page

“Hardy Diagnostics Strep B Carrot Broth One-Step: Incorrect Expiration Date.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64115-hardy-diagnostics-strep-b-carrot-broth-one-step-incorrect-expiration. Based on FDA recall #Z-0441-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2021%22&limit=1).

Hardy Diagnostics recalled Strep B Carrot Broth One-Step, Ref. Z40, because the outer box labeling contains an incorrect expiration date of 2021-11-10 instead of the correct date of 2020-11-10, according to the FDA. The agency announced the voluntary Class III recall on 2020-10-06.

How to tell if you have it

Brand: Hardy Diagnostics
Product: Strep B Carrot Broth One-Step
Reference: Z40
UDI: 00819398026499
Lot #: 465086
Quantity: 8,620 units

The hazard

The Streptococcus culture medium contains an incorrect expiration date on its outer box labeling. The label shows 2021-11-10 rather than the correct expiration date of 2020-11-10.

Context

GovInfoNow's records show Hardy Diagnostics has 6 other recalls on record since 2019-11-14, including a 2026-06-08 recall for HardyDisk AST Cefiderocol 30μg FDC30 due to false susceptibility results risk and a 2025-05-06 recall for HardyCHROM CRE Culture Media involving Klebsiella Pneumoniae breakthrough risk. Other recent recalls of similar products include Cook Medical Wayne Pneumothorax Tray Recall (2026-03-05), Cook Medical Blue Rhino G2 Tracheostomy Tray Recall (2026-03-05), and Cook Medical Spectrum Central Venous Tray Recall (2026-03-05).

How to tell if you have this one

Check for the product name 'Strep B Carrot Broth One-Step', reference number Z40, and unique device identifier (UDI) 00819398026499. The product was sold with lot number 465086.

Brand
Hardy Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Expiration Date
Verify the expiration date on the packaging; it should be November 10, 2020, not November 10, 2021.

Where it went and when

Where it was distributed

Distributed in 20 states and Puerto Rico.

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Idaho, Michigan, Minnesota, Missouri, Montana, New Hampshire, New York, North Carolina, Puerto Rico, Texas, Virginia, Washington, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Oct 6, 2020Firm started the recall
Nov 9, 2020FDA classified it Class III
Nov 18, 2020Published in FDA’s Enforcement Report
May 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64115-hardy-diagnostics-strep-b-carrot-broth-one-step-incorrect-expiration">Hardy Diagnostics Strep B Carrot Broth One-Step: Incorrect Expiration Date (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0441-2021 (October 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0441-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.