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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 14
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
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