BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer PST Blood Collection Tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer PST Blood Collection Tubes, Catalog Numbers 368035 and 368036. The recall involves 1,436,228,004 units that were distributed worldwide, including nationwide in the United States.
The recall is due to reports of false elevation of carboxyhemoglobin (COHb) results. This issue occurs when venous blood gas samples collected with these specific tubes are analyzed using the IL GEM 4000 instrument. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and laboratories should stop using the affected tubes for venous blood gas samples intended for analysis on the IL GEM 4000 instrument. Users should contact Becton Dickinson for further instructions on how to return or dispose of the product.
The recalled product
- Product
- BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 1,436,228,004
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)30382903680352
- (01)30382903680369
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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