CLASS III Device recall · Reported 18 Nov 2020 · FDA Enforcement Report

Strep B Carrot Broth One-Step recalled by Hardy Diagnostics

Hardy Diagnostics is recalling Strep B Carrot Broth One-Step, distributed in 21 states. The recall was initiated on 6 Oct 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 465086

Quantity recalled8,620 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0441-2021
FDA event ID: 86586
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class III
Status: Terminated
Recall initiated: 6 Oct 2020
FDA classified: 9 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Oct 2020	Recall initiated by company
9 Nov 2020	Classified by FDA	+34 days
18 Nov 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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

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

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # 465086

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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