Siemens Medical Solutions Diagnostics
Complete recall history across all FDA and CPSC categories — 8 total recalls
Siemens Medical Solutions Diagnostics 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 Siemens Medical Solutions Diagnostics
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 5, 2015 | Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are conti... | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Mar 5, 2015 | Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi ... | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Mar 5, 2015 | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi... | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Mar 5, 2015 | Direct Water feed Kit, Catalog#10373222 | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Mar 5, 2015 | Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are ... | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Mar 5, 2015 | Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 sy... | The bottle assemblies were manufactured with a quality issue where in some ca... | Class II |
| Apr 25, 2014 | VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s... | The keyboard and monitor may not be properly secured to the monitor arm. | Class III |
| Feb 3, 2014 | IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are c... | There is a potential for incorrect results to be reported from processing of ... | 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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