FDA recall Z-0933-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

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 for recall

The product was stored incorrectly due to improper storage controls which may lead to delayed results.

Distribution

Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.

Key facts

Status
Terminated
Initiation date
2022-03-08
Report date
2022-04-20
Termination date
2023-02-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2022