Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access SARS-CoV-2 IgG II assay [Ref: C69057; Lot: 922896,922953,922813, 124142, 124141, 124140; Expiry Date: 2021-05-31, 2021-05-31, 2021-04-30, 2021-05-31, 2021-05-31, 2021-04-30].
The manufacturer has identified a difference between the Access 2 / UniCel DxI Instrument Instructions for Use (IFU) and the result descriptions that display for samples containing more than the stated value of the highest Access SARS-CoV-2 IgG II Calibrator (S5).
This issue does not impact the interpretation of samples with concentrations that are greater than the Access SARS-CoV-2 IgG II Calibrator S5 value (highest calibrator). The sample result still maintains the OVR flag, which indicates that the sample concentration is above the highest calibrator (S5) value.
The manufacturer advised that the new assay protocol file will be released in April 2021 and affected users should follow the advice listed on the customer letter.
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 15 March 2021