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.
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 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
- Manufacturer
- Becton Dickinson & Company
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.
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