Sterling Diagnostics, Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Sterling Diagnostics, 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 (9)

FDA medical device enforcement actions by Sterling Diagnostics, Inc.

Date Product Reason Class
Jul 20, 2016 Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOS... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in ... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in ... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOS... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITR... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the qu... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in th... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III
Jul 20, 2016 Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC U... Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagn... Class III

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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