Sentinel CH SpA: Iron Assay Diagnostic Kits Recalled Due to Falsely Elevated Results

Agency Publication Date: November 17, 2023

Summary

Sentinel CH SpA has recalled approximately 8,794 Iron assay kits, including the Alinity c Iron Reagent and IRON assay for Architect instruments, due to a defect that causes falsely high iron test results. Internal studies confirmed that patient samples could show results up to 15% higher than actual levels on Alinity instruments and up to 30% higher on Architect instruments. These inaccurate readings can lead to incorrect medical diagnoses or delays in treatment if a quality control failure occurs. Consumers and healthcare providers should identify affected lots and contact the manufacturer for further instructions.

Risk

The affected diagnostic kits can report falsely elevated iron levels in patients, potentially leading to inappropriate clinical management or delayed results if the laboratory's quality control checks fail.

What You Should Do

Identify if you have affected IRON assay kits for Abbott Architect instruments by checking for Reference Number 6K95-41 (Lot 30610Y600) or Reference Number 6K95-30 (Lots 21058Y600, 21101Y600, 30918Y600).
Identify if you have affected Alinity c Iron Reagent kits for Abbott Alinity instruments by checking for Reference Number 08P3920 (Lots 21046Y600, 21118Y600, 30227Y600, 30302Y600).
Verify the UDI-DI on the packaging: 00380740010928 for REF 6K95-41, 00380740010911 for REF 6K95-30, or 00380740136253 for REF 08P3920.
If you possess any of these affected lots, contact your healthcare provider or Sentinel CH SpA to discuss the impact on previous test results and to receive instructions on replacement or potential refunds.
Laboratories should immediately stop using the affected lots and follow the instructions provided in the firm's notification letter.
For additional information, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: IRON assay (Reference Number 6K95-41)

Model / REF:

6K95-41

UPC Codes:

00380740010928

Lot Numbers:

30610Y600

Product: IRON assay (Reference Number 6K95-30)

Model / REF:

6K95-30

UPC Codes:

00380740010911

Lot Numbers:

21058Y600

21101Y600

30918Y600

Product: Alinity c Iron Reagent (Reference Number 08P3920)

Model / REF:

08P3920

UPC Codes:

00380740136253

Lot Numbers:

21046Y600

21118Y600

30227Y600

30302Y600

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93298

Status: Active

Manufacturer: Sentinel CH SpA

Sold By: Abbott Laboratories; Medical Diagnostic Facilities

Manufactured In: Italy

Units Affected: 2 products (4394 kits; 4400 kits)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have affected IRON assay kits for Abbott Architect instruments by checking for Reference Number 6K95-41 (Lot 30610Y600) or Reference Number 6K95-30 (Lots 21058Y600, 21101Y600, 30918Y600).

Identify if you have affected Alinity c Iron Reagent kits for Abbott Alinity instruments by checking for Reference Number 08P3920 (Lots 21046Y600, 21118Y600, 30227Y600, 30302Y600).

Verify the UDI-DI on the packaging: 00380740010928 for REF 6K95-41, 00380740010911 for REF 6K95-30, or 00380740136253 for REF 08P3920.

If you possess any of these affected lots, contact your healthcare provider or Sentinel CH SpA to discuss the impact on previous test results and to receive instructions on replacement or potential refunds.

Laboratories should immediately stop using the affected lots and follow the instructions provided in the firm's notification letter.

For additional information, contact the FDA medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: IRON assay (Reference Number 6K95-41)

Model / REF:

6K95-41

UPC Codes:

00380740010928

Lot Numbers:

30610Y600

Product: IRON assay (Reference Number 6K95-30)

Model / REF:

6K95-30

UPC Codes:

00380740010911

Lot Numbers:

21058Y600

21101Y600

30918Y600

Product: Alinity c Iron Reagent (Reference Number 08P3920)

Model / REF:

08P3920

UPC Codes:

00380740136253

Lot Numbers:

21046Y600

21118Y600

30227Y600

30302Y600