FDA (Devices) recall action 76962
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
The agency’s own wording, quoted from the enforcement report.
Beckman Coulter is recalling Triglycerides Reagent because specific drugs can cause false low results.
Beckman Coulter is recalling Lactate Reagent (Catalog No. A95550) because certain drugs can cause false low results.
Beckman Coulter is recalling Cholesterol Reagent (Catalog No. 467825) because specific drugs may cause false low results.
Beckman Coulter is recalling HDL Cholesterol Reagent because specific drugs can cause false low results.
Beckman Coulter is recalling Enzymatic Creatinine Reagent because specific drugs can cause false low results. The recall affects 12,665 units distributed worldwide.
Beckman Coulter is recalling Salicylate Reagent (Catalog No. 378194) because specific drugs can cause false low results in salicylate testing.
Beckman Coulter is recalling Uric Acid Reagent because certain drugs can cause false low results. The recall covers 100,286 units distributed worldwide.