BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results
Becton Dickinson is recalling specific blood collection tubes because they may cause falsely elevated 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 involves a risk of harm (false test results) without reported injuries or illnesses, which aligns with 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 PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962. The recall involves 1,436,228,004 units that were distributed worldwide, including 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 FDA has classified this as a Class II recall.
Healthcare facilities and laboratories that use these tubes with the IL GEM 4000 instrument should stop using the affected product and contact Becton Dickinson for further instructions. Patients who have had blood tests using these tubes should consult their healthcare provider if they have concerns about their results.
The recalled product
- Product
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
- 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)30382903679622
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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