Chromsystems Instruments & Chemicals GmbH
Complete recall history across all FDA and CPSC categories — 9 total recalls
Chromsystems Instruments & Chemicals GmbH 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 Chromsystems Instruments & Chemicals GmbH
| Date | Product | Reason | Class |
|---|---|---|---|
| May 19, 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | Too low concentration of glycine was detected in the dried blood controls of ... | Class II |
| May 19, 2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Too low concentration of glycine was detected in the dried blood controls of ... | Class II |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Produ... | XXX | Class II |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Prod... | XXX | Class II |
| Nov 2, 2020 | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The... | Products do not meet stability criteria and may impact results. | Class II |
| Nov 2, 2020 | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Produc... | Products do not meet stability criteria and may impact results. | Class II |
| Oct 29, 2020 | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Produc... | Control lots may not meet stability criteria and could result in increased re... | Class II |
| Oct 29, 2020 | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Produ... | Control lots may not meet stability criteria and could result in increased re... | Class II |
| Oct 29, 2020 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order N... | Calibrator lots may not meet stability criteria and could result in increased... | 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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