Alerta De Seguridad para COULTER Ac•T Pak Reagent Kit, COULTER Ac•T Tainer Reagent Kit, COULTER Diff Ac•T Pak and COULTER Diff Ac•T Tainer

Safety alert

2015-09-08

2015-09-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150908b.html

Medical device safety alert: beckman coulter coulter ac•t pak reagent kit, coulter ac•t tainer reagent kit, coulter diff ac•t pak and coulter diff ac•t tainer medical device manufacturer, beckman coulter inc, has issued a medical device safety alert for the ac•t 8/10 series, ac•t diff™ and ac•t diff2™ hematology systems. the affected reagent part numbers and lot numbers are identified as follows: coulter ac•t pak reagent kit: reagent reference 8547110; reagent lot numbers 112079k through 112094k coulter ac•t tainer reagent, kit: reagent reference 8547111 and; reagent lot numbers113075k through 113087k coulter diff ac•t pak, 15l: reagent reference 8547134; reagent lot numbers112077k through 112097k coulter diff ac•t tainer, 4l: reagent reference 8547135; reagent lot numbers113074k through 113090k the manufacturer has received an increased number of service calls and customer complaints related to the hemoglobin (hgb) parameter on the ac‧t series analyzers. an investigation revealed that the issues may have been related to variability in a component of the diluents which in turn may lead to a film coating the inside of the wbc bath where the hgb is measured. the issue is not observed with all analyzers. the use of the diluent lots mentioned above may eventually result in a compromised wbc bath. symptoms include: failures in hgb background at startup or during a background cycle. increases in hgb incomplete computations (....). unexpected variations between the hgb & hct (hematocrit) indicated by the asterisk (*) flag have not been reported. test results are not affected. the manufacturer will take actions to address hgb issues. wbc baths are currently being replaced as needed. all new shipments of ac‧t reagents containing diluents are currently being manufactured with a component that does not exhibit this variability. 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 8 september 2015.