Z-2463-2015Class II

HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged...

Name: Z-2463-2015 HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged...
Creator: Hardy Diagnostics
Published: 2015-07-09
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2015-07-09 / Terminated

FDA source

Hardy Diagnostics began a recall of HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light... on 2015-07-09. FDA classified it as Class II and gives the reason as "Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2463-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-09
Posted: 2015-08-26
Terminated: 2015-11-10
Recalling firm: Hardy Diagnostics
Product: HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
FDA root cause: Unknown/Undetermined by firm
Action: The firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.
Quantity in commerce: 2,820 (282 pk/10)
Distribution: Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
Product codes and lots: Cat no. G307 Lot no. H15155

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2463-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2463-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code JSO

K102922Class IIHardychrom MrsaHardy Diagnostics / cleared 2011-05-04

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)