Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access hsTnI (High Sensitivity Troponin I) assay [Reference: B52699; All Lots] to address potential intra-assay carryover with the Access hsTnI assay.
Through customer feedback and internal investigations, the manufacturer has determined that testing a sample with cardiac troponin I (cTnI) concentrations that are >270,000 pg/mL (ng/L) may cause carryover into the hsTnI reagent pack. The Access hsTnI quantifiable range is up to ~270,000 pg/mL (ng/L).
Typically, troponin I concentrations >270,000 pg/mL (ng/L) are characteristic of a subset of patients who have undergone aggressive cardiac intervention and/or experienced inordinately extensive myocardial injury. Such an elevated troponin concentration is not routinely observed in patients presenting to the emergency department with chest pain. While rare, clinically significant carryover can impact the results of all subsequent samples that are tested with the same reagent pack.
According to the manufacturer, if a sample with cTnI >270,000 pg/mL (ng/L) is tested using the Access hsTnI assay, then clinically significant carryover could be observed in all subsequent samples tested from the same reagent pack. Technical investigations demonstrate that the extent of carryover is directly proportional to the cTnI concentration that is present in the high sample.
Affected users are advised to take the following actions:
The manufacturer has updated the Limitations section of the Access hsTnI IFU to include the information provided with the Important Product Notice.
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 April 2020