FDA recall Z-0554-2022
MEDLINE INDUSTRIES, LP - Northfield · Class II · device
Product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Reason for recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Distribution
US Nationwide distribution in the state of California.
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-01
- Report date
- 2022-02-09
- Termination date
- 2023-01-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2022