Z-1125-2021 Class II Terminated
FDA device recall Z-1125-2021 was initiated by Confirm Biosciences Inc on January 29, 2021 and is designated Class II. 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 … The recall status is terminated (terminated December 13, 2022). Affected quantity: 563,840 cassettes.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- January 29, 2021
- Termination Date
- December 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 563,840 cassettes
Product Description
Reason for Recall
Distribution Pattern
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.