COVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution
Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per regulatory standards. Although no illnesses or injuries have been reported, the distribution of COVID-19 tests without FDA clearance or authorization is the basis for this Severe classification.
Plain-English summary
Woodside Acquisitions Inc. is recalling Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits. The recall affects 34,240 units of the product. All lots of the recalled test kits are included in this Class I recall.
The tests were distributed without FDA clearance or authorization for marketing or distribution in the United States. These rapid diagnostic tests for COVID-19 were not reviewed or approved by the FDA before being marketed to consumers.
The affected test kits were distributed to Alabama and Georgia. Consumers who obtained these test kits should not rely on them for COVID-19 diagnosis and should consult a healthcare provider for properly authorized diagnostic testing options.
The recalled product
- Product
- Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
- Manufacturer
- Woodside Acquisitions Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 34,240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Woodside Acquisitions Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Woodside Acquisitions Inc.
See all →- SevereCOVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance
FDA (Devices) · 2022-05-18
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