Zeus Scientific, Inc.

Complete recall history across all FDA and CPSC categories — 4 total recalls

Zeus Scientific, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Zeus Scientific, Inc.

Date Product Reason Class
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M The organization completed a product improvement process to the conjugate fou... Class II
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G The organization completed a product improvement process to the conjugate fou... Class II
Aug 12, 2019 ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage... FDA inspection identified that due to increased positivity (false positives) ... Class II
Jul 22, 2019 Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... Assay files used on the open Dynex DSX Instrument to process IVD ELISA sample... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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