The Recall Desk
SevereFDA (Devices)·Z-1044-2022·Announced 2022-05-18

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
  • unvalidated

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

Distributed in 2 states:

  • AL
  • GA

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