The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0718-2022·Announced 2022-03-16

FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization

Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.

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 recall for an unauthorized medical device. Although no illnesses or injuries have been reported, unauthorized COVID-19 diagnostic tests represent a serious regulatory violation and pose risk due to unknown accuracy and unverified performance.

Plain-English summary

Lusys Laboratories, Inc. is recalling COVID-19 IgG/IgM Antibody Test kits (Catalog No. I-111), an antibody rapid test intended for detection of COVID-19 IgG and IgM antibodies. Approximately 33,955 kits are affected by this recall.

The recall is being issued because these test kits are not authorized, cleared, or approved by the U.S. Food and Drug Administration for marketing or distribution in the United States. All lots of this product are subject to recall due to lack of required regulatory authorization. The FDA has classified this as a Class I recall.

The affected kits have been distributed in the United States through California, North Carolina, Nevada, Ohio, Tennessee, and Texas, as well as internationally to Canada, China, and Mexico, with additional distribution locations pending confirmation.

The recalled product

Product
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Manufacturer
Lusys Laboratories, Inc.
Category
Medical Device — Diagnostic Test
Hazard
Affected units
33,955

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Lusys Laboratories, 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 3 products in this recall →

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