FDA Medical Device Recalls (openFDA)
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 receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
- Recall number
- Z-2298-2020
- Recalling firm
- Hardy Diagnostics
- 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
- Status
- Terminated
- Initiated
- 2019-11-14
- Posted
- 2020-06-09
- Terminated
- 2021-04-28
- 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,
- Lot, serial or model codes
- Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
- 510(k) numbers
- ["K102922"]
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28