Hologic recalls Aptima CMV Quant Assay reagents (AW-22600-001, AW-25509-001, AW-26381-001) due to potential error codes when used with plasma specimens. Affected units may invalidate samples.
“Hologic Aptima CMV Quant Assay Recall: Error Codes from Plasma Specimens.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57320-hologic-aptima-cmv-quant-assay-recall-error-codes-from-plasma. Based on FDA recall #Z-1371-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1371-2024%22&limit=1).
Hologic, Inc. recalled Aptima CMV Quant Assay and related reagents because use with plasma specimens may cause an error code that invalidates samples, according to the FDA on Sept. 14, 2023.
The FDA said the hazard is that use of the assay along with plasma specimen may result in an error code which would invalidate the sample.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on record since 2017-06-27. Other recent recalls of similar products include Hologic Aptima HPV Assay Kit Recall (2026-02-18), Hologic Genius Review Station Display Recall (2026-03-23), and Hologic 3D Mammography Systems Recall (2026-04-08). Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13).
How to tell if you have this one
Check for reference numbers AW-22600-001, AW-25509-001, or AW-26381-001 on the reagent packaging. The lot number 402941 or UDI 15420045514553 may also indicate the affected units.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Packaging
Look for reference numbers AW-22600-001, AW-25509-001, or AW-26381-001 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain, Italy, Norway, Qatar, Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Florida, Idaho, Illinois, Maryland, Michigan, Missouri, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1371-2024 (September 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1371-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.