BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.
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 3/5 (High).
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, and the hazard involves a risk of harm (misleading diagnostic results) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884. 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 when venous blood gas samples collected with these tubes are analyzed using the IL GEM 4000 instrument. This issue may affect healthcare facilities and laboratories using the specific combination of these collection tubes and the IL GEM 4000 analyzer.
Healthcare providers 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 affected product.
The recalled product
- Product
- BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
- 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)30382903678847
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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