Z-2152-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- June 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496 units
Product Description
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Reason for Recall
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
Distribution Pattern
US: North Carolina OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands
Code Information
UDI: 15099590211615/Lot: 250106D, 250203C, 250203D, 250303C, 250331C, 250428C, 250526C