The Recall Desk
ModerateFDA (Devices)·Z-0404-2022·Announced 2021-12-29

Stanbio TDM/B-Hydroxybutyrate Controls Recalled Due to Improper Storage Temperature

Medline Industries is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls due to improper storage conditions. The product was shipped at room temperature instead of the required refrigerated environment.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is improper storage temperature for laboratory control materials, making this a precautionary, non-injury-related recall.

Plain-English summary

Medline Industries, LP is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Model No. S-O2460605. The affected batches were shipped from the warehouse at room temperature instead of the required refrigerated environment.

Affected batch numbers include 161603, 165148, 156205, 158144, 169124, 171961, and 175250. Approximately 14 units were distributed nationwide to laboratory customers in Illinois, Ohio, Mississippi, and Pennsylvania.

Laboratories that received affected batches should contact Medline Industries for product replacement or further guidance.

The recalled product

Product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • improper-storage

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 (10)

  • Model No.: S-O2460605
  • Batch No.: 161603
  • 165148
  • 156205
  • 158144
  • 169124
  • 171961
  • and 175250
  • Serial No.:161603
  • and 175250.

Distribution

Distributed nationwide across the United States.