Accelerate Diagnostics Inc
Complete recall history across all FDA and CPSC categories — 4 total recalls
Accelerate 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 (4)
FDA medical device enforcement actions by Accelerate Diagnostics Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 17, 2022 | Accelerate PhenoTest BC kit REF 10102018 | Due improperly formulated and released bulk lot of fluorescence in situ hybri... | Class II |
| Oct 17, 2022 | Accelerate PhenoTest BC kit REF 10101018 | Due improperly formulated and released bulk lot of fluorescence in situ hybri... | Class II |
| Mar 14, 2018 | Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Ac... | The kits may produce an elevated rate of false positive calls for the Staphyl... | Class II |
| Mar 13, 2017 | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1,... | Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Mini... | 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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