# FDA recall Z-1135-2021

> **Medline Industries Inc** · Class III · device recall initiated 2021-01-15.

## Product

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

## Reason for recall

Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market,  due to the product being compromised during shipment.

## Distribution

US Nationwide distribution in the states of MS, OH, IL.

## Key facts

- **Recall number:** Z-1135-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-15
- **Report date:** 2021-03-03
- **Termination date:** 2023-01-09

- **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-1135-2021

## Citation

> AI Analytics. FDA recall Z-1135-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1135-2021. Source: US FDA. Licensed CC0.

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