FDA-Device2023-11-29Class II
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Sentinel CH SpA
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
4394 kits
Manufactured in
Via Robert Koch 2, N/A, Milan, N/A, Italy
Products
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2024Don't want to check this manually?
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