HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detec
FDA device recall Z-2298-2020 · posted 2020-06-09 · Terminated
Recall details
- Recalling firm
- Hardy Diagnostics
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 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,
- Date initiated
- 2019-11-14
- Date posted
- 2020-06-09
- Date terminated
- 2021-04-28
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARDYCHROM MRSA (K102922) | Hardy Diagnostics | 2011-05-04 |