FDA (Devices) recall action 73667
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Healthcare Diagnostics is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Dimension Uric Acid assays because N-Acetylcysteine and Metamizole can cause falsely low results.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.
Siemens is recalling Direct HDL Cholesterol assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens is recalling Dimension Vista Triglyceride assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Advia Chemistry Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens is recalling Dimension Vista Enzymatic Creatine assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Dimension Assays: Triglycerides (TGL) because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens is recalling ADVIA Chemistry Glucose Oxidase Assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine assays because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens Healthcare Diagnostics is recalling the Advia Chemistry Assay: Direct HDL Cholesterol due to potential falsely depressed results caused by NAC or Metamizole interference.
Siemens Healthcare Diagnostics is recalling Advia Chemistry Assay: Lactate units because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens is recalling Advia Chemistry Assay: LDL Cholesterol, Direct because N-Acetylcysteine and Metamizole can cause falsely depressed results.
Siemens is recalling ADVIA Chemistry Enzymatic Creatinine 2 reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.