# FDA recall Z-1407-2021

> **Medline Industries Inc** · Class II · device recall initiated 2021-03-15.

## Product

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

## Reason for recall

Possible false negative or false positive results due to the product being compromised during shipment.

## Distribution

US Nationwide distribution in the state of Ohio.

## Key facts

- **Recall number:** Z-1407-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-15
- **Report date:** 2021-04-21

- **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-1407-2021

## Citation

> AI Analytics. FDA recall Z-1407-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1407-2021. Source: US FDA. Licensed CC0.

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