CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Aptima CMV Quant Assay, Reference numbers: AW recalled by Hologic
Hologic is recalling Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001, distributed nationwide in the US. The recall was initiated on 14 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1371-2024
- FDA event ID
- 94038
- Recalling firm
- Hologic, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Sep 2023
- FDA classified
- 22 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Sep 2023 | Recall initiated by company | |
| 22 Mar 2024 | Classified by FDA | +190 days |
| 3 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.
Where it was distributed
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.
Nationwide CaliforniaConnecticutFloridaIdahoIllinoisMarylandMichiganMissouriTennesseeTexasWisconsin
Stores named: Target
Questions about this recall
Why was it recalled?
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Which lots are affected?
Lot #: 402941/ UDI:15420045514553
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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