Recall Z-0933-2022— MEDLINE INDUSTRIES, LP - Northfield
Class II · Terminated
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-03-08, terminated 2023-02-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product was stored incorrectly due to improper storage controls which may lead to delayed results..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-08
- Terminated
- 2023-02-27
- Firm location
- Northfield, IL, United States
Product description
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.
Reason for recall
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.