Recall Z-2033-2024 ยท GTY Antigens, All Groups, Streptococcus Spp.
Wondfo USA Co Ltd
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
| Date | Jun 7, 2024 (initiated Apr 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| 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 |
| Quantity | 102,500 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.