# FDA recall Z-2545-2025

> **Quidel Corporation** · Class II · device recall initiated 2025-06-17.

## Product

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

## Reason for recall

Dipstick strep A test has potential for false positive results.

## Distribution

Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.

## Key facts

- **Recall number:** Z-2545-2025
- **Recalling firm:** Quidel Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-17
- **Report date:** 2025-09-17

- **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-2545-2025

## Citation

> AI Analytics. FDA recall Z-2545-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2545-2025. Source: US FDA. Licensed CC0.

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