Testosterone Assay Cross-Contamination Recall Due to Inadequate Maintenance
Beckman Coulter's Access Testosterone assay (Lot 538081) may produce inaccurate results due to cross-contamination from inadequate maintenance of the fill line. Results could be up to 34% higher or 23% lower than actual values.
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 a Class II FDA recall of a medical diagnostic device. No deaths or hospitalizations have been reported. The hazard is potential inaccurate test results due to cross-contamination, which poses a risk of patient harm through incorrect clinical decisions, but injury has not yet been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Beckman Coulter, Inc. is recalling Access Testosterone assay, Catalog Number 33560 (Lot 538081), a medical diagnostic test used to measure testosterone levels.
The recall was initiated because inadequate preventative maintenance on the scales of the RPL5 fill line led to cross-contamination (splashing) between wells of testosterone reagent packs. The contamination could cause test results to be inaccurate—potentially 34% higher or 23% lower than actual values.
The affected product was distributed to facilities in Florida (US), the United Arab Emirates, and Vietnam. Seventy units of this lot were distributed.
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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