BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.
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 diagnostic error (false elevation of carboxyhemoglobin) which poses a risk of harm through potential misdiagnosis or inappropriate treatment, fitting the criteria for a high-risk product where injury has not yet been explicitly reported as a physical injury but represents a significant clinical risk.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667. 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.
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 instructions on returning the product or obtaining replacements.
The recalled product
- Product
- BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
- Manufacturer
- Becton Dickinson & Company
- 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 (1)
- UDI: (01)30382903666677
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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