Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its HbA1c (Hemoglobin A1c) Reagent [Ref: B00389; Lot: 1052B, 1052D, 1053B; Expiry Date: 1 Oct 2021 & 1 Jan 2022].
The manufacturer advised that the in-kit value assignment sheets (VAS) contained in the affected products have a 2D barcode printed on them which should not be present, as it is not suitable for use with the HbA1c in-kit calibrator on the DxC 700AU Beckman Coulter Analysers. When the 2D barcode is scanned it will not update the calibrator values, instead the values from the previous lot used on the instrument will be retained.
The corrected VAS is now available on the manufacturer's website and affected users are advised not to scan the 2D barcode on the calibrator value assignment sheet that comes packaged in the kit. They should manually enter the required calibrator information.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Jul 2021