BD Vacutainer Blood Collection Tubes Recalled for False COHb Results
Becton Dickinson is recalling specific 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 criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963. 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 or injuries resulting from this defect.
Healthcare facilities and laboratories should stop using these 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 handle the affected inventory.
The recalled product
- Product
- BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
- 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 (1)
- UDI: (01)30382903679639
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.
See all 15 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · false test results
See all →- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- SevereBeckman Coulter MicroScan Panel Update DVD Kits Recalled
FDA (Devices) · 2026-08-12
- HighRespiratory Diagnostic Cartridges Recalled for Risk of False Test Results
FDA (Devices) · 2025-04-09
- HighMedical Device Recall: PTH Assay on DxI 9000 Analyzer May Produce Inaccurate Results
FDA (Devices) · 2024-12-18
- HighSiemens Atellica CH diagnostic reagent carryover may cause false laboratory test results
FDA (Devices) · 2023-09-06