FDA (Devices) recall action 79225
The FDA (Devices) publishes a recall like this one as 17 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 17 pages.
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
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 is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.
Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Tacrolimus Assay because it may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.
Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.
Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.
Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Siemens Healthcare Diagnostics is recalling Dimension Vista Ammonia assays because they may produce inaccurate results when used with certain drugs.