Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results
Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.
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: This is an FDA Class II recall of laboratory equipment with no reported illnesses or injuries. The hazard involves potential inaccurate test results from a device defect, which qualifies as a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
Beckman Coulter, Inc. is recalling 213 cases containing 2,130,000 Ringed DxI Reaction Vessels (RVs), which are components of Unicel DxI Immunoassay Systems (600 and 800 series). These vessels are used in laboratory testing equipment.
The recall was issued because three affected lot numbers (L17855111, L17798598, L18046334) failed the company's internal service test for washing efficiency. The failure caused rough interior surfaces on the vessels, which can lead to increased relative light units (RLU) readings and artificially elevated test results in susceptible assays, including sandwich immunoassays such as hsTnI, Hybritech p2PSA, and IPTH/IPTH IO tests.
The recalled vessels were distributed worldwide, with U.S. distribution confirmed in California, Massachusetts, Texas, New Jersey, Michigan, Georgia, North Carolina, Florida, and West Virginia. International distribution also includes Qatar. No illnesses or injuries have been reported.
Healthcare facilities and laboratory personnel using affected equipment should contact Beckman Coulter, Inc. immediately for guidance on the recalled lot numbers and appropriate corrective actions.
The recalled product
- Product
- Ringed DxI Reaction Vessels (RVs)
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- inaccurate-test-results
- defective-component
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 (5)
- UDI: 15099590229979
- Catalog Number: 386167
- Lot Numbers: L17855111
- L17798598
- L18046334
Distribution
Distributed nationwide across the United States.
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