FDA recall Z-1939-2020

Remel Inc. · Class II · device

Product

SWIN 2017 database, Model YSW4000

Reason for recall

Potential for out of range microbial results

Distribution

...

Key facts

Status
Terminated
Initiation date
2019-01-04
Report date
2020-05-20
Termination date
2020-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakwood Village, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1939-2020