The customer observed falsely elevated alinity c magnesium results for multiple patient samples.The following data was provided (reference range 0.66 to 1.07 mmol/l): sample id (b)(6); initial result = 2.69 mmol/l, repeat = 0.84 mmol/l sample id (b)(6); initial result = 2.47 mmol/l, repeat = 0.82 mmol/l no impact to patient management was reported.
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After further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, a.I.D.D longford, lisnamuck, co.Longford, longford, ireland, n39e932 to alinity c processing module, list number 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2023-00037-00 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, to alinity c processing module, list number 03r67-01.Mdr number 3016438761-2023-00037-00 has been submitted and all further information will be documented under that mdr number.
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