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Open, Classified

Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

FDA Recall Z-1045-2022 · Posted None

Recalling FirmWoodside Acquisitions Inc.
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-04-09
Product Quantity17,000 units

Reason for Recall

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Firm Action

On April 9, 2022, the firm notified affected distributors via email with subject line "IMPORTANT!!! Recall Notice". The attached recall letter instructed distributors to immediately return all unused product to the recalling firm for a refund. If distributors have further distributed the product, they should forward the recall information to all affected customer accounts. The firm may be reached Monday through Friday, 9:00 AM to 4:30 PM, Eastern Time at 814-218-2804.

Root Cause

No Marketing Application

Distribution Pattern

US distributions to states of: AL and GA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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