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AMS Diagnostics, LLC

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

AMS Diagnostics, LLC 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 AMS Diagnostics, LLC

Date Product Reason Class
Feb 29, 2016 Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe... Lot was not functioning properly and not exhibiting the correct physical prop... Class III
Feb 11, 2014 AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nit... Marketing the devices outside 510(k) requirements Class II
Feb 11, 2014 AMS AST For the In vitro quantitative determination of AST in serum Quant... Marketing the devices outside 510(k) requirements Class II
Feb 11, 2014 AMS URIC ACID For the In vitro quantitative determination of Uric Acid in ser... Marketing the devices outside 510(k) requirements 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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