FDA (Devices) recall action 64570
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
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 2,207 Dimension EXL LM analyzers worldwide due to increased System Check failures that cause inconvenience but do not affect test results.
Siemens is recalling 2,207 Dimension EXL LM STM analyzers worldwide due to System Check failures that cause inconvenience but do not affect test results.
Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL 200 analyzers worldwide due to increased System Check failures that cause inconvenience but do not impact test results.