Roche received complaints from US customers for Creatine Kinase (CK) lot 755471 (expired June-2024) on cobas c 311/501/502 and INTEGRA 400 plus about abnormal calibration signals, flagged calibrations (Sens.E) and control recovery issues. Subsequent investigation identified a positive bias at the lower measuring range and a negative bias at the higher measuring range. The issue affects a small number of cassettes of the mentioned lot. Recall Start Date: August 19, 2024
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