BD Vacutainer Blood Collection 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 specific instruments.
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 a risk of harm through inaccurate diagnostic results (false elevation of COHb), which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494. 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 using venous blood gas samples collected with these tubes and analyzed with the IL GEM 4000 instrument. This issue may lead to inaccurate diagnostic readings for patients.
Healthcare facilities and laboratories should stop using the affected blood collection tubes. Users should contact Becton Dickinson & Company for further instructions on how to handle the recalled product and obtain replacements if necessary.
The recalled product
- Product
- BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
- 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)30382903680352
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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