The Recall Desk
ModerateFDA (Devices)·Z-0932-2022·Announced 2022-04-20

Hydroxybutyrate Test Kits Recalled Due to Improper Storage

Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalization. The hazard is improper storage causing delayed test results—a quality and timing issue rather than a direct safety threat. Per the rubric, recalls without reported harm are typically Moderate.

Plain-English summary

Medline Industries is recalling Hydroxybutyrate LiquiColor Tests (Model/Item No. S-O2440058), consisting of three bottle sizes: 3mL, 8.5mL, and 50mL. The recall affects 45 total units.

The recalled products were improperly stored, which may result in delayed test results. The FDA has classified this as a Class II recall.

The affected lots (171793, 169614, 167181, 171713) were distributed in the United States to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Nebraska, New York, Ohio, Pennsylvania, Virginia, and Washington.

The recalled product

Product
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • improper-storage
  • delayed-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model/Item No. S-O2440058
  • Lots 171793
  • 169614
  • 167181
  • 171713 UDI: 00657498000519

Distribution

Distributed in 16 states:

  • AL
  • CA
  • FL
  • GA
  • IL
  • IN
  • LA
  • MO
  • MS
  • NC
  • NE
  • NY
  • OH
  • PA
  • VA
  • WA