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 is classified as FDA Class II, and the hazard involves inaccurate diagnostic results (false elevation of COHb) which poses a risk of harm to patient care, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964. 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 lead to inaccurate diagnostic readings for patients.
Healthcare facilities and laboratories should stop using these specific tubes for venous blood gas samples intended for analysis on the IL GEM 4000 instrument. Users should contact Becton Dickinson for instructions on how to return the affected products.
The recalled product
- Product
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
- 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)30382903679646
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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