Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 diagnosi

U.S. FDA — Device Enforcement · United States · 2020-10-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0426-2021
Date of alert: 2020-10-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Epitope Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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