BD Vacutainer Luer Lok Access Device may shed particles causing false test results
BD's Vacutainer Luer Lok Access Device may release contaminant particles that can be misidentified as red blood cells in laboratory analysis, potentially leading to false elevated RBC counts.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class III designation with no reported illnesses or injuries. The hazard is theoretical—particles may shed and be misidentified, potentially leading to diagnostic errors, but no actual harm has been reported. This qualifies as a risk-of-harm product without reported injury.
Plain-English summary
BD Vacutainer Luer Lok Access Device (catalog numbers 364902 and 36490200), manufactured by Becton Dickinson & Company, has been recalled. The device is a sterile, single-use connector intended for blood and urine sample collection from catheterized patients.
The device may shed contaminant particles into urine specimens. When these specimens are analyzed using Sysmex UF-1000i or UX-2000 analyzers, particles may be misidentified as red blood cells, potentially resulting in false elevations in RBC counts on laboratory results.
This recall affects users of the device with the specified analyzers. A total of 288,152,790 units have been distributed nationwide in the United States.
The recalled product
- Product
- BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog…
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device
- Affected units
- 288,152,790
Distribution
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