Hardy Diagnostics: Medical Device Recall in 2020 - (Recall #: Z-2298-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 14, 2019

Date Posted: June 17, 2020

Recall Number: Z-2298-2020

Event ID: 85412

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.

Status: Terminated

Product Quantity: 3,580 ea (358 kits, pack of 10 in each)

Code Information:

Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated