Z-2192-2015Class II

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

Name: Z-2192-2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate...
Creator: Hardy Diagnostics
Published: 2015-06-24
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2015-06-24 / Terminated

FDA source

Hardy Diagnostics began a recall of 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 2015-06-24. FDA classified it as Class II and gives the reason as "Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2192-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-07-22
Terminated: 2015-08-28
Recalling firm: Hardy Diagnostics
Product: 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.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
FDA root cause: No Marketing Application
Action: The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at [email protected].
Quantity in commerce: 1,500
Distribution: Distributed to one U.S. customer in SC.
Product codes and lots: Cat No.: G333 Lot No.: H15055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2192-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2192-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code JSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)