Z-2298-2020Class II

HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative...

Name: Z-2298-2020 HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative...
Creator: Hardy Diagnostics
Published: 2019-11-14
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2019-11-14 / Terminated / root cause: manufacturing process

FDA source

Hardy Diagnostics began a recall of HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by... on 2019-11-14. FDA classified it as Class II and gives the reason as "False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2298-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Posted: 2020-06-09
Terminated: 2021-04-28
Recalling firm: Hardy Diagnostics
Product: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 11/14/2019, the firm sent a notification of recall letter to customers, informing them of the performance issue of the device lot of the breakthrough on firm's differential chromogenic medium. The customers were advised to discard the remaining stock, and notify the Technical Services Department. If the customer would like replacement or credit, contact Technical Services Department or via e-mail at [email protected], or 800-266-2222 option 2 or ext. 5658.
Quantity in commerce: 3,580 ea (358 kits, pack of 10 in each)
Distribution: U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya,
Product codes and lots: Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2298-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2298-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-08

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)