| Class 2 Device Recall Wondfo Preview | |
Date Initiated by Firm | April 22, 2024 |
Date Posted | June 07, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2030-2024 |
Recall Event ID |
94261 |
Product Classification |
Antigens, all groups, streptococcus spp. - Product Code GTY
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Product | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 |
Code Information |
a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W03910902, W03911002, W03910911, W03921005, W03921102, W03921008, W039212001, W039212006, W03920804;
b) PRE-STA-10, UDI/DI **, Lot Numbers: W03920902, W03921103, W039307002, W039306008, W03931002 |
Recalling Firm/ Manufacturer |
Wondfo USA Co Ltd 545 Willowbrook Center Pkwy Ste B Willowbrook IL 60527-8436
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For Additional Information Contact | 866-769-0168 |
Manufacturer 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 Determined Cause 2 | 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 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.
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Quantity in Commerce | 1,238,755 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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