Food, drugs, devices › Hardy Diagnostics

Device recall: HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10

FDA enforcement event 71577 · Class II · initiated 24 Jun 2015 · status Terminated · terminated 28 Aug 2015

DeviceVoluntary: Firm initiated1 product recordSanta Maria, CA

Hardy Diagnostics (Santa Maria, CA) initiated this device recall on 24 Jun 2015; FDA lists 1 product record under event 71577, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 28 Aug 2015. Initiation: voluntary: firm initiated. Hardy Diagnostics has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Hardy Diagnostics, Santa Maria, CA.

Reason for recall

"Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance."

Distribution

"Distributed to one U.S. customer in SC."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2192-2015	HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.	1,500	Class II	Terminated	29 Jul 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for 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
6 Oct 2020	Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499	Device	Class III	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

All 14 events for Hardy Diagnostics

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed to one U.S. customer in SC."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Aug 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.