Z-2031-2024Class II

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid...

Name: Z-2031-2024 Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid...
Creator: Wondfo USA Co Ltd
Published: 2024-04-22
License: https://open.fda.gov/license/

Wondfo USA Co., Ltd. / initiated 2024-04-22 / Open, Classified

FDA source

Wondfo USA Co Ltd began a recall of 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... on 2024-04-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2031-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-22
Posted: 2024-06-07
Recalling firm: Wondfo USA Co., Ltd.
Product: 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
Product code: GTY Antigens, All Groups, Streptococcus Spp.
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.
FDA root cause: No Marketing Application
Action: The firm issued an URGENT: MEDICAL DEVICE RECALL notice its consignees on 04/22/2024 via USPS Certified mail. The notice explained the issue, risk to health, and requested the following: Actions to be taken by all consignees/customers " Unless the user facility meets the CLIA requirements (noted above), discontinue/quarantine the Preview Strep A Test Kit (and other applicable device brand names not mentioned above) marketing and distribution. This distribution hold should continue until further notification from Wondfo USA. o In addition, contact Customer Service via telephone at +1(630) 468-2199 or by mail sending correspondence to; 545 Willowbrook Center Pkwy. #B Willowbrook, IL 60527, USA or e-mail [email protected]. At that time, provide device information such as product code, lot number and quantity to be returned. Customer Service will provide shipping instructions, as well as prepaid labels. Credits for returned product will be applied upon receipt of the devices. o Furthermore, if you are a user of devices for which lot numbers are not listed on this notice, please contact customer service via telephone or email as listed above for further instructions. " Forward this Advisory Notice to all customers who purchased any affected devices during the timeframe from March 2022 up to the current date. " Make certain to inform the end-users of the following: o End-users outside of the intended use setting should return the affected devices immediately, as appropriate, to the distributor where they purchased the product. o Individuals tested within the last month who experience symptoms related to Strep A infection should contact their primary care provider. Test results obtained within the past month should be reviewed by appropriate health providers.
Quantity in commerce: 170,000 units
Distribution: US Nationwide distribution.
Product codes and lots: a) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W039306003; b) CD-STP25V, Lot Numbers: CD-STP25V W03920404, W039302002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2031-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2030-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2031-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2032-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2033-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07
Z-2034-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07

Product code GTY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)