Public recall detail

Alinity C Iron Reagent Kit

2023-10-16

medium
Recall Safety notice
Quick summary

Quick summary: Alinity C Iron Reagent Kit. Date: 2023-10-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alinity C Iron Reagent Kit. Date: 2023-10-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSentinel Ch. Spa
ProductAlinity C Iron Reagent Kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74426

Affected products

ProductIron
Lot30918Y600 30610Y600 21101Y600 21058Y600
Model6K95-41 6K95-30
Serial number30918Y600 30610Y600 21101Y600 21058Y600
DescriptionIron
ProductAlinity C Iron Reagent Kit
Lot30227Y600 21118Y600 30302Y600 21046Y600
Model08P3920
Serial number30227Y600 21118Y600 30302Y600 21046Y600
DescriptionAlinity C Iron Reagent Kit

Issue

Sentinel Ch Spa, the manufacturer of iron for use with Architect and Alinity C Iron Reagent Kit, has identified an issue with the reagents. Some customers have experienced elevated quality control (QC) results as well as elevated patient results. 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 30% for iron products (iron ref. 6k95-41 and iron ref. 6k95-30) to be used on Abbott Architect instrument. Recall start date: September 29, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesSentinel Ch. Spa Via Robert Koch, 2, Milan, Italy, 20152
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74426
Background{}
CompaniesSentinel Ch. Spa Via Robert Koch, 2, Milan, Italy, 20152
AudiencesHealthcare
Source updated2023-10-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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