EDI Novel Coronavirus COVID-19 IgG ELISA Kit recall
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…
Why was EDI Novel Coronavirus COVID-19 IgG ELISA Kit 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: P826, P815, P796, P776
- 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…
- Recalling firm
- Epitope Diagnostics, Inc.
- Quantity
- 2886
- Distribution
- U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.
- Recall date
- November 18, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)