Z-2298-2020 Class II Terminated
FDA device recall Z-2298-2020 was initiated by Hardy Diagnostics on November 14, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 28, 2021). Affected quantity: 3,580 ea (358 kits, pack of 10 in each).
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- November 14, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,580 ea (358 kits, pack of 10 in each)
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.
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,
Code Information
Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140