# FDA recall Z-0968-2018

> **Becton Dickinson & Company** · Class II · device recall initiated 2017-08-29.

## Product

BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL).  Catalog Number: 367841.    Used for whole blood hematology determinations, immunohematology testing and blood donor screening.

## Reason for recall

A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.

## Distribution

Nationwide Distribution

## Key facts

- **Recall number:** Z-0968-2018
- **Recalling firm:** Becton Dickinson & Company
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-29
- **Report date:** 2018-03-21
- **Termination date:** 2019-05-16

- **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-0968-2018

## Citation

> AI Analytics. FDA recall Z-0968-2018. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0968-2018. Source: US FDA. Licensed CC0.

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