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Z-1537-2021 Class I Ongoing

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

FDA device recall Z-1537-2021 was initiated by INNOVA MEDICAL GROUP, INC. on Apr 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: 370 boxes (=2,590 individual tests).

Recall Details

Product Type: Devices
Report Date: Jun 16, 2021
Initiation Date: Apr 9, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 370 boxes (=2,590 individual tests)

Product Description

COVID-19 Self-Test Kit *** INNOVA *** 7T

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: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1537-2021
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.