Z-1044-2022 Class I Ongoing
FDA device recall Z-1044-2022 was initiated by Woodside Acquisitions Inc. on April 9, 2022 and is designated Class I. Reason for recall: Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. The recall status is ongoing. Affected quantity: 34,240 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2022
- Initiation Date
- April 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,240 units
Product Description
Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
Reason for Recall
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Distribution Pattern
US distributions to states of: AL and GA.
Code Information
All lots