Sentinel CH SpA

Complete recall history across all FDA and CPSC categories — 8 total recalls

Sentinel CH SpA 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 (8)

FDA medical device enforcement actions by Sentinel CH SpA

Date Product Reason Class
Sep 29, 2023 Alinity c Iron Reagent, Reference Number 08P3920 A high recovery of Iron assay has been observed at some customer sites. Inte... Class II
Sep 29, 2023 IRON assay, Reference Numbers 6K95-41 and 6K95-30 A high recovery of Iron assay has been observed at some customer sites. Inte... Class II
Jul 29, 2021 Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials w... Class III
Apr 30, 2021 ACE Control Set - IVD Control set for the quantitative determination of Angio... Claim for stability after reconstitution from lyophilized to liquid form does... Class III
Jun 28, 2019 Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in se... Added an additional SmartWash parameter for the Lithium and Alinity c Lithi... Class II
Jun 28, 2019 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasm... Added an additional SmartWash parameter for the Lithium and Alinity c Lithi... Class II
May 22, 2017 MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. ... Reagent 1 component may result in Quality Control values shifting out of acce... Class II
Sep 22, 2015 Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia mea... Results for ammonia are below the linear range of the assay for samples that ... 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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