Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity c Activated Alanine Aminotransferase Reagent Kit (A‐ALT) [List Number: 08P1820; Lot Number: 83459UN20, 03168UN20, 09787UN20, 37977UN20, 63000UN20, 77745UN20, 77743UN21, 09237UN21]
The manufacturer states that the product linearity specification may not be met when using A‐ALT reagent as it approaches lot expiration. According to the manufacturer, internal testing demonstrated a potential of > 10% under‐recovery on A‐ALT samples greater than 1200 U/L. It also showed a >10% shift in patient results with samples containing bilirubin concentration greater than 31mg/dL.
Affected users are advised to install A-ALT assay file, version 7 immediately. Furthermore, the High Linearity assay parameter has been reduced from 4772 U/L to 1200 U/L to prevent the potential for incorrect results. An updated IFU will be released and affected users should follow the advice listed on the customer letter.
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 16 Jun 2021