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Class 2 Device Recall Orient Gene COVID 19 IgG/ IgM Rapid Test Cassette |
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| Date Initiated by Firm |
January 29, 2021 |
| Create Date |
February 16, 2021 |
| Recall Status1 |
Terminated 3 on December 13, 2022 |
| Recall Number |
Z-1126-2021 |
| Recall Event ID |
87263 |
| Product Classification |
Reagent, coronavirus serological - Product Code QKO
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| 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 from anticoagulated blood or serum. |
| Code Information |
Catalog Number: HE Cassette COVID 19 Lot Numbers: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, 2005213 |
Recalling Firm/
Manufacturer |
Confirm Biosciences Inc
10123 Carroll Canyon Rd
San Diego CA 92131-1109
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| For Additional Information Contact |
Bonnie Filosa
800-908-5603
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Manufacturer Reason
for Recall |
Due to two (2) issues:
1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories.
2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
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FDA Determined
Cause 2 |
Other |
| Action |
On 01/29/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Notification its customers and distributors informing them that Recalling Firm may have distributed products to facilities that do not meeting the conditions outline in the Emergency Use Authorization (EUA) which stipulates that only laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests are authorized to receive and utilize the products. Use of these tests by non-certified laboratory facilities may result in false-positive test results and may lead to an incorrect assessment, such as mistaken immune response to the COVID-19 virus and may delay treatment and risk the further spread of infection to others. The Recalling Firm is planning on sending a follow-up Customer Notification Letter via UPS on or about 02/12/2021.
The "URGENT: MEDICAL DEVICE RECALL" Notification instructs customers:
1) To minimize unauthorized use of these products, discontinue the use these products outside of a CLIA accredited or compliant Moderate or High Complexity laboratory setting.
2) Acknowledge the receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: Regulatory@confirmbiosciences.com
Customer are asked to complete the response form and return immediately, no later than March 31, 2021.
To correct this issue, the Recalling Firm will work with its customers to either:
-Affirm the Customers authorization to use these products through their CLIA Number and Status
-Coordinate the return of unused, unopened products to the Recalling Firm.
For any questions regarding this recall, call 800-908-5602 or email Regulatory@confirmbiosciences.com (Monday thru Friday 8:00 a.m. to 4:00 p.m. Pacific Time) |
| Quantity in Commerce |
2,003,053 cassettes |
| Distribution |
Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina,
Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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