Recalls / —
—#179298
Product
SWIN 2017 database, Model YSW4000
- FDA product code
- LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- ...
Why it was recalled
Potential for out of range microbial results
Root cause (FDA determination)
Software design
Action the firm took
Technicians replaced YSW514-17 with YSW514-17A.
Recalling firm
- Firm
- Remel Inc.
- Address
- 1 Thermo Fisher Way, Oakwood Village, Ohio 44146-6536
Distribution
- Distribution pattern
- ...
Timeline
- Recall initiated
- 2019-01-04
- Terminated
- 2020-08-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179298. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.