BD Microtainer Tubes Recalled for Damaged Reservoirs and Erroneous Test Results
Becton Dickinson is recalling specific lots of BD Microtainer Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves erroneous test results due to improper sample volumes, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Becton Dickinson & Company is recalling specific lots of BD Microtainer Tubes with LH (Lithium Heparin), Part/Catalog No. 365965. The recall affects lots 811767N, 815066N, 821471N, and 821990N, which were distributed nationwide and in various foreign countries.
The recall is being issued 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.
No specific instructions for consumers are provided in the source text, as these are medical devices typically used by healthcare professionals. Users should verify their lot numbers against the recall list.
The recalled product
- Product
- BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
- 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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