Sentinel CH SpA
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Sentinel CH SpA and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-11-29FDA-DeviceClass IIAlinity c Iron Reagent, Reference Number 08P3920
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
- 2023-11-29FDA-DeviceClass IIIRON assay, Reference Numbers 6K95-41 and 6K95-30
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
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