Original mdr was filed 2016-08-02.Analysis of the instrument and instrument data indicate that the cause for the discrepant ca results is related to a flex reagent cartridge well set issue.The low results were obtained from a single well set.Siemens healthcare diagnostics has completed an investigation of calcium (ca) flex® reagent cartridge lot 16060bb.It has been confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 16060bb may produce erroneously low results from specific well sets.If calibration is performed using an unaffected well set and samples are subsequently run using an affected well set, ca results may be falsely depressed up to -2.9 mg/dl (-0.72 mmol/l).Bias for serum, plasma, and urine specimens are similar.If calibration is performed using an affected well set, ca results for patient and qc samples from subsequent unaffected well sets may be falsely elevated.An urgent medical device recall communication, vc-16-05.A.Us, and an urgent field safety notice, vc-16-05.A.Ous dated august 9, 2016 was issued to customers who had been shipped lot 16060bb.Customers were instructed to discontinue use and to discard the lot.Siemens offered a no charge replacement for discarded reagent.
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