Recall Z-0426-2021 ยท QKO Reagent, Coronavirus Serological
Epitope Diagnostics, Inc.
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.
| Date | Oct 1, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 10/01/20, the firm, Epitope Diagnostics Inc. (EDI), sent "URGENT: EDI" Novel Coronavirus COVID-19 IgG ELISA Kit Recall" notices were sent to customers. Customers were asked to do the following: Results where the assay controls do not meet the manufacturer's defined specifications should be considered invalid and repeated with another lot. Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Complete and promptly return the Custom |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.