BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results
Becton Dickinson is recalling BD Vacutainer LH 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 is classified as FDA Class II. The hazard involves diagnostic inaccuracy (false elevation of COHb) which poses a risk of harm through potential misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886. 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 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 & Company for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
- 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)30382903666646
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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