# FDA recall Z-2307-2019

> **Becton Dickinson & Company** · Class II · device recall initiated 2019-06-12.

## Product

BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056

## Reason for recall

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

## Distribution

Worldwide Distribution, including US Nationwide

## Key facts

- **Recall number:** Z-2307-2019
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-12
- **Report date:** 2019-08-28
- **Termination date:** 2020-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franklin Lakes, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2307-2019

## Citation

> AI Analytics. FDA recall Z-2307-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2307-2019. Source: US FDA. Licensed CC0.

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