Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotec

FDA device recall Z-2034-2024 · posted 2024-06-07 · Open, Classified

Recall details

Recalling firm

Wondfo USA Co Ltd

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.

Action taken

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 recalls@wondfousa.com. 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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

GTY

Distribution

US Nationwide distribution.

Date initiated

2024-04-22

Date posted

2024-06-07

Location

Willowbrook, IL