Recall Z-2298-2020 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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
| Date | Jun 9, 2020 (initiated Nov 14, 2019) |
| Status | Terminated |
| Reason | False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. |
| 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 TechService@HardyDiagnostics.com, or 800-266-2222 option 2 or ext. 5658. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102922 | HARDYCHROM MRSA Hardy Diagnostics, May 4, 2011 |