Confirm Biosciences Recalls Healgen COVID-19 Rapid Test Cassettes
Confirm Biosciences is recalling Healgen COVID-19 Rapid Test Cassettes because they were distributed to non-certified labs and not validated for fingerstick use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a diagnostic device that was not adequately validated for its intended use, posing a risk of harm through inaccurate results without reported injuries.
Plain-English summary
Confirm Biosciences Inc is recalling 563,840 Healgen COVID-19 IgG/IgM Rapid Test Cassettes (Whole Blood/Serum/Plasma). The recall was initiated due to two specific issues: the firm distributed the test cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories, and the cassettes were not adequately validated for their intended use, specifically fingerstick tests for in-home use or testing.
The affected product is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood, or serum. The recall covers Lot Numbers 2006167eua, 2006168eua, and 2006169eua, with Catalog Number HE Cassette COVID 19EUA.
The product was distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Consumers and healthcare providers should stop using the affected cassettes and contact the firm for further instructions.
The recalled product
- Product
- Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from…
- Manufacturer
- Confirm Biosciences Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 563,840
Distribution
Part of a larger recall action
This product is one of 2 recalled by Confirm Biosciences 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
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