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Recall Observatory FDA recall evidence

Device product

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

Z-0932-2022

March 08, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 89857
Status
Terminated
Classification
Class II
Quantity
45 ea
Official record key
device-enforcement:Z-0932-2022

Official wording

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

Code information: Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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