BD Microtainer Tubes Recalled for Damaged Reservoirs Causing Test Errors
Becton Dickinson is recalling BD Microtainer Tubes with K2E because damaged reservoirs may cause insufficient sample volume 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 a risk of harm (erroneous test results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling BD Microtainer Tubes with K2E (K2EDTA), Catalog Number 365974. The recall is due to a defect where the damaged reservoir may lead to a decreased fill volume.
This defect can cause samples to be insufficient for testing and result in an improper blood-to-additive ratio. These issues may potentially produce erroneous test results.
The affected products were distributed nationwide and in multiple foreign countries. Users should check their inventory for the specific lot numbers listed in the official recall notice and stop using the affected tubes.
The recalled product
- Product
- BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
- 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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