BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Corrective action and recall for Stratus CS Analyzer of Dade Behring

Product group In-vitro diagnostics
Reference 01048/06

Corrective action and recall of Dade Behring for Stratus CS Analyzer BHCG TestPaK, CKMB TestPak, cTnI TestPak, DDMR TestPak, Myo TestPak, NT-proBNP TestPak. BHCG DilPak, CKMB DilPak, cTnI DilPak, DDMR DilPak, Myo DilPAK, NT-proBNP DilPak because of inaccurate test results. Customers were informed to discontinue the use of some specified batches; shelf-life time of other batches has been reduced.

Corrective action and recall for Stratus CS Analyzer of Dade Behring , Download_VeroeffentlichtAm_EN PDF, 153KB, File does not meet accessibility standards