BD Vacutainer Blood Collection Tubes Recalled for False COHb Results
Becton Dickinson is recalling BD Vacutainer PST Gel and Lithium Heparin 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 a risk of harm (inaccurate diagnostic 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) 56 Units Blood Collection Tubes, Catalog Number 368056. The recall involves 1,436,228,004 units that were distributed worldwide, including in the United States.
The recall is being issued 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 results for patients.
Healthcare facilities and laboratories that have used these tubes with the IL GEM 4000 instrument should stop using them and contact Becton Dickinson for further instructions. Consumers are not directly affected by this recall, as the product is intended for professional medical use.
The recalled product
- Product
- BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
- 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)30382903680567
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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