HardyCHROM MRSA,REF recallZ-2298-2020 · Hardy Diagnostics · initiated Nov 14, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hardy Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected], or 800-266-2222 option 2 or ext. 5658.
Recall details
- Recall number
- Z-2298-2020
- Status
- Terminated
- Initiated by the company
- Nov 14, 2019
- Posted by the FDA
- Jun 9, 2020
- Recalling firm
- Hardy Diagnostics
- Quantity
- 3,580 ea (358 kits, pack of 10 in each)
- Product code
- JSO
- FDA submissions
- K102922
- 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,
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
Code information (models, lots, serial numbers)
Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HardyCHROM™ G307Hardy Diagnostics · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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