Access Testosterone assay Catalog Number 33560 recalled
Beckman Coulter is recalling the Access Testosterone assay (Catalog Number 33560) due to inadequate maintenance on manufacturing equipment that caused cross-contamination in testosterone reagent packs, which could result in inaccurate patient test results.
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 medical device recall involving a diagnostic assay with potential for significant inaccuracy in patient results (up to 34% increase or 23% decrease). Although no reported illnesses or injuries are stated, the hazard is direct and not merely theoretical—the equipment malfunction demonstrably caused cross-contamination with documented potential for harm to patient care.
Plain-English summary
Beckman Coulter, Inc. is recalling the Access Testosterone assay, Catalog Number 33560 (UDI-DI: 15099590231347; Serial Number: 538081). The recall affects approximately 70 units distributed in Florida, United Arab Emirates, and Vietnam.
Inadequate preventative maintenance performed on the scales of the RPL5 fill line resulted in splashing and cross-contamination between the wells of testosterone reagent packs. This contamination could potentially cause testosterone test results to be inaccurate, with results potentially increased by up to 34% or decreased by up to 23%.
Healthcare providers and laboratory administrators who received affected units should contact Beckman Coulter for instructions on verification and corrective actions. Inaccurate testosterone results could impact patient care decisions.
The recalled product
- Product
- Access Testosterone assay, Catalog Number 33560
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- cross-contamination
- inaccurate-test-results
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 (2)
- UDI-DI: 15099590231347
- Serial Number: 538081
Distribution
Distributed in 1 state:
- FL
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