Estrone RIA diagnostic kits recalled for falsely elevated test results
Beckman Coulter recalls Estrone RIA kits due to manufacturing defects in coated tubes causing falsely elevated estrone measurements. Affected lots were distributed in North Carolina and internationally.
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: FDA Class II diagnostic device recall involving a manufacturing defect causing inaccurate test results. While no illnesses or injuries have been reported, this represents a risk-of-harm product where diagnostic inaccuracy could affect clinical decision-making.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of the Estrone RIA kit (REF: DSL8700), an in vitro diagnostic test used to measure estrone hormone levels in blood serum and plasma.
The recall was initiated due to a manufacturing defect in bovine serum albumin (BSA) used to coat tubes included with the kit. The defect caused the coated tubes to have reduced affinity for patient samples, resulting in test results that were falsely elevated.
The recall affects 496 units distributed to North Carolina in the United States and internationally to Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and the Netherlands. The affected lot numbers are 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, and 250526C.
Healthcare providers and diagnostic laboratories using affected kits should discontinue use and contact Beckman Coulter for product replacement.
The recalled product
- Product
- Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- inaccurate-results
- manufacturing-defect
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 (7)
- UDI: 15099590211615/Lot: 250106D
- 250203C
- 250203D
- 250303C
- 250331C
- 250428C
- 250526C
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03