FDA recall Z-0932-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)

Reason for recall

Product was improperly store which may cause a delay in results.

Distribution

US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA

Key facts

Status
Terminated
Initiation date
2022-03-08
Report date
2022-04-20
Termination date
2023-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0932-2022