Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0058-2020·Announced 2019-10-16

BD Microtainer SST- Amber Tubes Recalled for Damaged Reservoirs

Becton Dickinson is recalling specific lots of BD Microtainer SST- Amber tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, death, or high-risk pathogens, fitting the Moderate category for non-physical defects or low-risk contamination.

Plain-English summary

Becton Dickinson & Company is recalling specific lots of BD Microtainer SST- Amber tubes, identified by Part/Catalog Number 365978. The recall covers units distributed nationwide and in numerous foreign countries, including Argentina, Australia, Belgium, Brazil, Canada, China, India, Japan, and others.

The recall is being issued because a damaged reservoir in the tubes may lead to a decreased fill volume. This defect can cause blood samples to be insufficient for testing and result in an improper blood-to-additive ratio, which may produce erroneous laboratory results.

Healthcare facilities and laboratories should check their inventory for the specific lot numbers listed in the official recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text, as these are professional medical devices.

The recalled product

Product: BD Microtainer SST- Amber Part/Catalog Number: 365978
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection Tubes
Hazard: erroneous-results
insufficient-sample

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 →

Same manufacturer · Becton Dickinson & Company

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