Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning the following products:
Product Name:
* For these products, only insufficient homogenization has been observed on the field but no nonspecific reactions
Other reagents from the same product range not displaying the issue but requiring user's attention:
The manufacturer has observed two phenomena when using the affected products. The root cause for both these phenomena is highly suspected to be related to the type of glass vials used in the manufacturing of reagent red blood cells.
The first phenomenon concerns nonspecific reactions primarily observed on Quality Control (QC) samples but also with patient samples and eluates. Doubtful reactions or in some cases false positive reactions may occur randomly between batches and within a same batch. This phenomenon can appear with both manual and all automated methods.
The second phenomenon concerns insufficient homogenisation of the red blood cells within the vials when stored on-board either on the IH-500 or on the IH-1000 and when the remaining volume reaches 2ml or lower. This lack of homogenisation can lead to a dispense of low-concentrated red blood cell reagent into the wells of the ID-cards. According to the manufacturer, these two phenomena may result in false positive or false negative reaction.
The manufacturer advises affected users to follow immediate protective measure as listed on the user notification letter.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 30 December 2020