Alerta De Seguridad para Myoglobin Assay in Liquid Cardiac Control Level 1, 2 and 3

Safety alert

2017-02-24

2017-02-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170224.html

Medical device safety alert: randox laboratories myoglobin assay in liquid cardiac control level 1, 2 and 3 medical device manufacturer, randox laboratories, has issued a field safety notice (fsn) concerning its myoglobin assay in liquid cardiac control level 1, 2 and 3. details catalogue numbers and lot numbers as below:- catalogue numbers: 1) cq5051; 2) cq5052; 3) cq5053 lot numbers: 1) 3909ck, 3910ck, 3913ck; 2) 3911ck, 3990ck, 3991ck, 3992ck; 3) 3912ck the manufacturer has confirmed a change in recovery with regards to myoglobin in the lots of the liquid cardiac control listed above for the randox immunoturbidimetric method. internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method. recovery of myoglobin for other methods quoted in the instruction for use (ifu) has not been confirmed. customers using methods other than the randox immunoturbidimetric method should review their running internal quality control (iqc) mean for a shift in trend which may indicate a review of the control range is required. according to the manufacturer, iqc that is reported as out of range could lead to a delay in reporting myoglobin results. since serum myoglobin is not typically used in isolation for diagnosing cardiac injury a delay in reporting these results should not pose a serious risk to health. the manufacturer advises customers to remove the ifu from all unused stock and replace with the lot specific document. review results generated with the affected lots in line with the clinical profile of the patient and discuss the contents of the fsn with their medical director. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 february 2017.