Reported Nov 18, 2020 · Ongoing
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of…
Epitope Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Epitope Diagnostics, Inc. · 7110 Carroll Rd · San Diego, CA · 92121-2215
Is this the product you have?
- EDI Novel Coronavirus COVID-19 IgG ELISA Kit
- REFKT-1032
- Per labelThis 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
- Lot codes and dates
- Lot Numbers
P826P815P796P776
- Lot Numbers
- Amount recalled
- 2886
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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