FDAFDA · Food and drugs·Recall number Z-0426-2021
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.
Published November 18, 2020 · Recall initiated: October 1, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Epitope Diagnostics, Inc.
- Distributor
- U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.
- Lot
- Lot Numbers: P826, P815, P796, P776
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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