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Z-1539-2021 Class I Ongoing

Recalled by INNOVA MEDICAL GROUP, INC. — Pasadena, CA

FDA device recall Z-1539-2021 was initiated by INNOVA MEDICAL GROUP, INC. on April 9, 2021 and is designated Class I. Reason for recall: Due to distributing test kits to customers who were not part of a clinical investigation. The recall status is ongoing. Affected quantity: 402 boxes (=1,206 tests).

Recall Details

Product Type: Devices
Report Date: June 16, 2021
Initiation Date: April 9, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 402 boxes (=1,206 tests)

Product Description

COVID-19 Self-Test Kit *** INNOVA *** 3T

Reason for Recall

Due to distributing test kits to customers who were not part of a clinical investigation.

Distribution Pattern

Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

Code Information

Catalog Number: 3T Lot Numbers: U2102003 X2012310