Medical device manufacturer, Greiner Bio-One North America, Inc., has issued a medical device notification concerning its VACUETTE 2mL 9NC Coagulation Sodium Citrate Tube [Greiner Item Number: 454322; Greiner Lot Number: B1908355; IL Part Number: 00015098; IL Lot Number: 003712].
The manufacturer has received a report that some of the affected item/lot numbers of blood collection tubes experienced an issue with the amount of sodium citrate dispensed into the tube. During the tube assembly process, the VACUETTE 2mL Coagulation Sodium Citrate 3.2% Tubes were shown to have inconsistent amounts of the 3.2% sodium citrate. Sodium Citrate additive canister on the assembly line was overfilling causing an excess of citrate additive in about 0.05% of tubes. The observed amount of citrate overfill was found to be up to 2mL (10x) of the specified citrate amount per tube.
The 3.2% 9NC Coagulation Sodium Citrate tube is used to monitor anticoagulant therapy, such as heparin or warfarin. A citrate overfill may be detected by the user (i.e. phlebotomist) prior to venipuncture. A laboratory technician could detect the higher amount of citrate due to the greater amount of total specimen volume exceeding the fill-level mark. There may be a degree of overfilling which would not be detected by the user and lead to artificially prolonged PT and/or PTT and erroneous Fibrinogen results. This could result in the withholding or lowering the dose of heparin or warfarin, or the administration of vitamin K in a patient with therapeutic levels of anticoagulant. This in turn could lead to a thrombotic event. Clinical laboratory practice should verify any change in patients' prior test results before adjustments of anticoagulation therapy.
Affected users are instructed to take the following actions:
Product replacement is on-going.
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 21 July 2020