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, and the hazard involves a risk of harm (misdiagnosis due to false lab results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880. The recall involves 1,436,228,004 units that were distributed worldwide, including nationwide in the United States.
The recall was initiated because false elevation of carboxyhemoglobin (COHb) results have been reported when venous blood gas samples collected with these tubes are analyzed using the IL GEM 4000 instrument. This issue may lead to inaccurate diagnostic readings for patients tested with this specific combination of collection tubes and analyzer.
Healthcare facilities and laboratories should stop using the affected catalog number 367880 tubes for venous blood gas samples intended for analysis on the IL GEM 4000 instrument. Users should contact Becton Dickinson & Company for further instructions on how to return or dispose of the affected product.
The recalled product
- Product
- BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
- 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)30382903678809
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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