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

Class III FDA enforcement event 86586. Recall start date: 6 Oct 2020. Status in the FDA record: Terminated. Termination date: 28 May 2021.

Reason for recall, in the words of FDA

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

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Hardy Diagnostics started this device recall on 6 Oct 2020. The firm address in the FDA record is in Santa Maria, CA. FDA put the recall in Class III. FDA event 86586 has 1 product record. The first FDA enforcement report date is 18 Nov 2020. The record gives the status Terminated, with the termination date 28 May 2021.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

Hardy Diagnostics, Santa Maria, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86586: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0441-2021	Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499	8,620 units	Class III	Terminated	18 Nov 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class III: 3%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Hardy Diagnostics
Initiated	Product (first record)	Type	Class	Records
8 Jun 2026	HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susc	Device	Class II	1
6 May 2025	HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.	Device	Class II	1
16 Apr 2021	Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.	Device	Class II	1
21 Dec 2020	Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-2	Device	Class II	1
23 Oct 2020	Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provide	Device	Class II	1
14 Nov 2019	HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detec	Device	Class II	1
24 May 2016	QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counte	Device	Class II	1
21 Mar 2016	Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic	Device	Class II	1
18 Nov 2015	FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivat	Device	Class II	1
9 Jul 2015	HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/s	Device	Class II	1

Hardy Diagnostics: all 14 events

Official channels

FDA enforcement report Z-0441-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86586. https://recallregister.com/fda/iii/86586/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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
What quantity of product is in FDA event 86586?: The FDA record gives this quantity: 8,620 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 3% of the 916 device events that started in 2020 are in Class III.