Roche Diagnostics Operations, Inc.: Tina-quant D-Dimer Test Systems Recalled for Elevated Results Risk

Agency Publication Date: November 20, 2023

Summary

Roche Diagnostics Operations, Inc. is recalling approximately 5,263 Tina-quant D-Dimer Test System kits because they may produce incorrectly high (elevated) results when using Li-heparin plasma samples compared to standard citrated plasma samples. This recall affects the test systems used on several analyzer models, including the cobas c 311, 501, 502, 503, 303, and INTEGRA 400 plus. Consumers and healthcare providers should be aware that inaccurate test results could lead to improper medical assessments.

Risk

Incorrectly elevated D-dimer results can lead to false-positive findings, potentially resulting in unnecessary medical procedures, misdiagnosis of blood clotting disorders, or inappropriate treatment plans for patients.

What You Should Do

Identify if your laboratory or healthcare facility is using the affected Tina-quant D-Dimer Test System kits by checking the Material Numbers and UDIs on the packaging.
Check for Material Number 03001245322 (UDI 04015630914593) used with cobas c 311, 501, 502, and INTEGRA 400 plus systems.
Check for Material Number 08105618190 (UDI 07613336133651) used with cobas c 303 and 503 systems.
Contact your healthcare provider or Roche Diagnostics Operations, Inc. at their Indianapolis headquarters for specific technical guidance regarding the use of Li-heparin plasma samples with these kits.
For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer consultation

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

Affected Products

Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay (cobas c 311, 501 and 502; INTEGRA 400 plus)

Model / REF:

03001245322

UPC Codes:

04015630914593

Lot Numbers:

All Lots Affected

Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay (cobas c 303 and 503)

Model / REF:

08105618190

UPC Codes:

07613336133651

Lot Numbers:

All Lots Affected

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93282

Status: Active

Manufacturer: Roche Diagnostics Operations, Inc.

Sold By: Direct distribution to healthcare facilities and laboratories

Manufactured In: United States

Units Affected: 5,263 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 your laboratory or healthcare facility is using the affected Tina-quant D-Dimer Test System kits by checking the Material Numbers and UDIs on the packaging.

Check for Material Number 03001245322 (UDI 04015630914593) used with cobas c 311, 501, 502, and INTEGRA 400 plus systems.

Check for Material Number 08105618190 (UDI 07613336133651) used with cobas c 303 and 503 systems.

Contact your healthcare provider or Roche Diagnostics Operations, Inc. at their Indianapolis headquarters for specific technical guidance regarding the use of Li-heparin plasma samples with these kits.

For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay (cobas c 311, 501 and 502; INTEGRA 400 plus)

Model / REF:

03001245322

UPC Codes:

04015630914593

Lot Numbers:

All Lots Affected

Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay (cobas c 303 and 503)

Model / REF:

08105618190

UPC Codes:

07613336133651

Lot Numbers:

All Lots Affected