The Recall Desk
ModerateFDA (Devices)·Z-0061-2020·Announced 2019-10-16

BD Microtainer Tubes Recalled Due to Damaged Reservoirs

Becton Dickinson is recalling specific lots of BD Microtainer Tubes with FE Glycolytic Inhibitor because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves erroneous test results due to insufficient sample volume, which is a significant quality issue but does not involve direct physical injury or death, fitting the Moderate severity criteria for low-risk contamination or quality defects.

Plain-English summary

Becton Dickinson & Company is recalling specific lots of BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor, Part/Catalog Number 365992. The affected lots are 8212777, 8212785, 8268546, and 8268549. These products were distributed nationwide and in various foreign countries.

The recall was initiated because a damaged reservoir may lead to a decreased fill volume. This can cause samples to be insufficient for testing and result in an improper blood-to-additive ratio, potentially producing erroneous results.

Healthcare facilities and laboratories should check their inventory for the specific lot numbers listed above. If these products are found, they should be removed from use and returned to Becton Dickinson & Company according to the company's instructions.

The recalled product

Product
BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →