CLASS II ONGOING Device recall · Reported 19 Jun 2024 · FDA Enforcement Report
Clarity and Clarity Diagnostics LLC recalled by Wondfo USA Co
Wondfo USA Co is recalling Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a), distributed nationwide in the US. The recall was initiated on 22 Apr 2024 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-2031-2024
- FDA event ID
- 94261
- Recalling firm
- Wondfo USA Co, Willowbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2024
- FDA classified
- 7 Jun 2024
- Reported
- 19 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Apr 2024 | Recall initiated by company | |
| 7 Jun 2024 | Classified by FDA | +46 days |
| 19 Jun 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
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Product as listed by the FDA
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) recalled?
Yes. Wondfo USA Co recalled Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) on 22 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2031-2024.
Why was it recalled?
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Which lots are affected?
a) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W039306003; b) CD-STP25V, Lot Numbers: CD-STP25V W03920404, W039302002
Where was it sold?
US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wondfo USA Co
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Independent Medical Co-op Inc. recalled by Wondfo USA Co | Wondfo USA Co | Other | Nationwide |
| Device | CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA Co | Other | Nationwide |
| Device | CLASS II | Streptococcal A rapid test kits, labeled as recalled by Wondfo USA Co | Wondfo USA Co | Other | Nationwide |
| Device | CLASS II | Preview Strep A, Streptococcal A rapid test kits recalled | Wondfo USA Co | Other | Nationwide |
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