Corrective action and recall of Sysmex for SF-3000 Haematology Analyzer
2005.04.14
Product group In-vitro diagnostics
Reference 00311/05
Corrective action and recall of Sysmex for SF-3000 Haematology Analyzer software version 00-28. Under specific circumstances the affected software can cause sample misidentifications. Software version 00-28 has been developed in the context of another corrective action. The customers were informed about the problem and how to avoid it. See also BfArM case number 0311/05 from March 14th 2005.