Medical Device Linearity Standards Recalled Due to Improper Storage Controls
Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six 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 involving storage control issues that may affect test result timing. No illnesses or injuries have been reported, and the hazard is a quality and reliability concern rather than an acute safety threat.
Plain-English summary
Medline Industries, LP is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards (REF 2450-604) due to improper storage controls. These are laboratory standards used in diagnostic testing for therapeutic drug monitoring and beta-hydroxybutyrate measurement.
The products were stored incorrectly, which may lead to delayed test results. The recall involves 10 boxes containing Levels 1-6 standards (1 x 4 mL each) distributed to healthcare facilities in Alabama, Florida, Nebraska, Ohio, Texas, Washington, and Wisconsin.
Affected lot numbers include 172093 (expiration 06/30/2023), 174703 (expiration 08/31/2023), and 169141 (expiration 04/30/2023). No illnesses or injuries have been reported.
Healthcare providers and laboratories should contact Medline Industries for instructions on handling or replacement of affected standards.
The recalled product
- Product
- Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- improper-storage
- test-result-delay
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 (6)
- Lot numbers 172093
- exp. 06/30/2023
- 174703
- exp. 08/31/2023
- and 169141
- exp. 04/30/2023.
Distribution
Distributed in 7 states:
- AL
- FL
- NE
- OH
- TX
- WA
- WI
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