Sentinel CH SpA: Medical Device Recall in 2023 - (Recall #: Z-0325-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

IRON assay, Reference Numbers 6K95-41 and 6K95-30

Product Classification:

Class II

Date Initiated: September 29, 2023

Date Posted: November 29, 2023

Recall Number: Z-0325-2024

Event ID: 93298

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 4394 kits

Code Information:

Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated