# FDA recall Z-0933-2022

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-03-08.

## 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

- **Recall number:** Z-0933-2022
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0933-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0933-2022. Source: US FDA. Licensed CC0.

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