CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report
QuickVue: Dipstick Strep A Test: 50T recalled by Quidel
Quidel is recalling QuickVue: Dipstick Strep A Test: 50T, distributed nationwide in the US. The recall was initiated on 17 Jun 2025 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-2545-2025
- FDA event ID
- 97271
- Recalling firm
- Quidel, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2025
- FDA classified
- 10 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2025 | Recall initiated by company | |
| 10 Sep 2025 | Classified by FDA | +85 days |
| 17 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Dipstick strep A test has potential for false positive results.
Product as listed by the FDA
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Where it was distributed
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.
Nationwide AlaskaCaliforniaColoradoFloridaIdahoIllinoisKansasLouisianaMassachusettsMarylandMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew YorkPennsylvaniaSouth CarolinaTennesseeTexas
Questions about this recall
Why was it recalled?
Dipstick strep A test has potential for false positive results.
Which lots are affected?
REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026); 20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026); 20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)
Where was it sold?
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.
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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|---|---|---|---|---|---|
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