The Recall Desk
HighFDA (Devices)·Z-1126-2021·Announced 2021-02-24

Confirm Biosciences Recalls Orient Gene COVID-19 Rapid Test Cassettes

Confirm Biosciences is recalling Orient Gene COVID-19 Rapid Test Cassettes because they were distributed outside Emergency Use Authorization and not validated for fingerstick use.

What this means for you

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 involves a medical device with a significant risk of harm due to lack of validation for intended use and distribution outside regulatory authorization, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Confirm Biosciences Inc is recalling approximately 2,003,053 units of the Orient Gene COVID-19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), Reference GCCOV-402a. The recall is 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, which includes fingerstick tests for in-home use and testing.

The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. The recall covers specific lot numbers: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, and 2005213.

Consumers and healthcare providers should stop using these test cassettes immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their healthcare provider for guidance on how to proceed.

The recalled product

Product
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-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 fro
Manufacturer
Confirm Biosciences Inc
Category
Medical Device — Diagnostic Test
Hazard
Affected units
2,003,053

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 (13)

  • Catalog Number: HE Cassette COVID 19 Lot Numbers: 2002198
  • 2003244
  • 2003285
  • 2003290
  • 2003291
  • 2003295
  • 2003308
  • 2004148
  • 2004158
  • 2005153
  • 2005154
  • 2005155
  • 2005213

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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 →

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