Hologic, Inc.: Aptima CMV Quant Assay Recalled for Potential Invalid Sample Results

Agency Publication Date: March 22, 2024

Summary

Hologic, Inc. is recalling 684 kits of the Aptima CMV Quant Assay, a diagnostic tool used to monitor Cytomegalovirus (CMV). When this assay is used with plasma specimens, it may trigger a specific error code that invalidates the sample. This issue affects kits with lot number 402941 and reference numbers AW-22600-001, AW-25509-001, and AW-26381-001. Approximately 684 kits were distributed nationwide across 11 states and internationally.

Risk

The software error results in an invalid test result, which could lead to delays in monitoring a patient's viral load or necessitate a repeat blood draw. While no patient injuries were reported, invalid results can interfere with critical clinical management decisions for patients undergoing CMV monitoring.

What You Should Do

Check your laboratory inventory for Aptima CMV Quant Assay kits with Lot Number 402941 (UDI: 15420045514553).
Verify if your kit includes Reference numbers AW-22600-001, AW-25509-001, or AW-26381-001, specifically looking at the Amplification, Enzyme, and Promoter reagents or reconstitution solutions.
If you have an affected kit, contact your healthcare provider or Hologic, Inc. to discuss the impact on recent testing and to obtain instructions on how to handle remaining inventory.
Follow the manufacturer's guidance regarding the use of plasma specimens with these specific lot numbers to avoid invalidating patient samples.
For further questions or technical support, contact Hologic, Inc. directly or call the FDA's medical device hotline at 1-888-463-6332.

Your Remedy Options

Other Action

Manufacturer Notification

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

Affected Products

Product: Aptima CMV Quant Assay

Model / REF:

AW-22600-001

AW-25509-001

AW-26381-001

Lot Numbers:

402941 (UDI: 15420045514553)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94038

Status: Active

Manufacturer: Hologic, Inc.

Manufactured In: United States

Units Affected: 684 kits

Distributed To: California, Connecticut, Florida, Idaho, Illinois, Maryland, Michigan, Missouri, Tennessee, Texas, Wisconsin

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

Risk

What You Should Do

Check your laboratory inventory for Aptima CMV Quant Assay kits with Lot Number 402941 (UDI: 15420045514553).

Verify if your kit includes Reference numbers AW-22600-001, AW-25509-001, or AW-26381-001, specifically looking at the Amplification, Enzyme, and Promoter reagents or reconstitution solutions.

If you have an affected kit, contact your healthcare provider or Hologic, Inc. to discuss the impact on recent testing and to obtain instructions on how to handle remaining inventory.

Follow the manufacturer's guidance regarding the use of plasma specimens with these specific lot numbers to avoid invalidating patient samples.

For further questions or technical support, contact Hologic, Inc. directly or call the FDA's medical device hotline at 1-888-463-6332.