Hardy Diagnostics 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Hardy Diagnostics
Lot Codes / Batch Numbers
Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
Products Sold
Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
Hardy Diagnostics is recalling HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qual due to False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Recommended Action
Per FDA guidance
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 TechService@HardyDiagnostics.com, or 800-266-2222 option 2 or ext. 5658.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IN, IA, KS, MO, MT, OR, TX, UT, WA, WI, WY, PR
Page updated: Jan 10, 2026