Epitope Diagnostics Recalls COVID-19 IgG ELISA Kits Due to Water Use
Epitope Diagnostics is recalling 2,886 units of its Novel Coronavirus COVID-19 IgG ELISA Kit because deionized water was used instead of distilled water during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Epitope Diagnostics, Inc. is recalling 2,886 units of the EDI Novel Coronavirus COVID-19 IgG ELISA Kit (REF: KT-1032). The affected lots are P826, P815, P796, and P776. The product is intended for the qualitative detection of human anti-COVID-19 IgG antibody in human serum.
The recall was initiated because deionized water was used rather than distilled water during the manufacturing process. This error may have resulted in accelerated decreased OD signals for the Positive Control value, potentially affecting the accuracy of the test results.
The affected products were distributed in the following U.S. states: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN. Users should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Epitope Diagnostics, Inc.
- Affected units
- 2,886
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: P826
- P815
- P796
- P776
Distribution
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