FDA Device recall 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…
- FDA Device
- Class II
- ongoing
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of 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… by Epitope Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0426-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-10-01 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Epitope Diagnostics |
| Distribution | CA, CO, FL, HI, IL, MA, MD, MI, NC, NH, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA |
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 cases require diagnosis or differential diagnosis of novel coronavirus infection.
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.
Identifiers
| code_info | Lot Numbers: P826, P815, P796, P776 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0426-2021%22
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