🔍 RecallPedia

Alinity c Iron Reagent, Reference Number 08P3920

Class I - Dangerous
🏥 Medical Devices Recalled: September 29, 2023 Sentinel CH SpA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sentinel CH SpA
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Alinity c Iron Reagent, Reference Number 08P3920

Product Codes/Lot Numbers:

UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0326-2024

Related Recalls

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

Sentinel CH SpA

Class I - Dangerous

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.

Sep 29, 2023 Other Medical Devices Nationwide View Details →

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

Sentinel CH SpA

Class I - Dangerous

Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.

Jul 29, 2021 Infusion Pumps Nationwide View Details →