PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 20, 2022 Initiated: March 8, 2022 #Z-0933-2022

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.

Details

Units Affected
10 boxes
Distribution
Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 10 boxes.
Why was this product recalled?
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0933-2022.