# FDA recall Z-1371-2024

> **Hologic, Inc.** · Class II · device recall initiated 2023-09-14.

## Product

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.

## Reason for recall

Use of assay along with plasma specimen may result in error code which would invalidate sample.

## 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.

## Key facts

- **Recall number:** Z-1371-2024
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-14
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1371-2024

## Citation

> AI Analytics. FDA recall Z-1371-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1371-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*