Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its ID‐DiaPanel Plus 6 (6x4 ml) [Catalog No: 004414; Serial/ Lot No: 642947231 / 45670231, 658764232 / 45670232; Expiry Date: 10.01.2022]
The manufacturer's internal investigation confirmed that the affected lots of red blood cells reagent may give unexpected reactions ("wR", "+/‐","1+") instead of a clear negative on cell 13 when used with IH‐QC 3, 4 and 5.It advises affected user that new lots of product are now available for replacement.
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 13 Dec 2021