Recall Z-0426-2021— Epitope Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Epitope Diagnostics, Inc., initiated 2020-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Epitope Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-10-01
- Firm location
- San Diego, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.