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
Reported: June 19, 2024 Initiated: April 22, 2024 #Z-2031-2024
Product Description
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
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.
Details
- Recalling Firm
- Wondfo USA Co Ltd
- Units Affected
- 170,000 units
- Distribution
- US Nationwide distribution.
- Location
- Willowbrook, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Wondfo USA Co Ltd. Units affected: 170,000 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2024. Severity: Moderate. Recall number: Z-2031-2024.
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