Recall Z-2298-2020— Hardy Diagnostics

Name: FDA recall Z-2298-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-14

Class II · Terminated

Class II FDA medical device recall by Hardy Diagnostics, initiated 2019-11-14, terminated 2021-04-28. It names one FDA 510(k) clearance: K102922. 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. Reason: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited..

Recalling firm: Hardy Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Terminated: 2021-04-28
Firm location: Santa Maria, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102922 — HARDYCHROM MRSAHardy Diagnostics·cleared 2011-05-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.