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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: 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.
- Affected units
- 70
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:
Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- HighBeckman Coulter Access System-Free T4 Assay Recalled for Biotin Interference
FDA (Devices) · 2017-07-05
- ModerateBeckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors
FDA (Devices) · 2015-11-18
- ModerateBeckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs
FDA (Devices) · 2015-09-09
- ModerateBeckman Coulter Cholesterol Assay Recalled Due to NAC Interference
FDA (Devices) · 2015-02-04
- ModerateBeckman Coulter Access Thyroglobulin Recalled for Biotin Interference
FDA (Devices) · 2017-07-05
- ModerateBeckman Coulter Access Total T3 Immunoassay Recalled for Biotin Interference
FDA (Devices) · 2017-07-05