Home / Recalls / Epitope Diagnostics, Inc. / Z-0426-2021

Z-0426-2021 Class II Ongoing

Recalled by Epitope Diagnostics, Inc. — San Diego, CA

Recall Details

Product Type: Devices
Report Date: November 18, 2020
Initiation Date: October 1, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2886

Product Description

EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

Reason for Recall

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

Distribution Pattern

U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.

Code Information

Lot Numbers: P826, P815, P796, P776