Z-0426-2021 Class II Ongoing
FDA device recall Z-0426-2021 was initiated by Epitope Diagnostics, Inc. on October 1, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2886.
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