Medical device manufacturer, Bio-Rad, has issued a medical device safety alert concerning its ID-Antigen Profile II [Catalogue Number: 008610; Lot Number: 503802901, SAP Lot Number: 5947322901; Expiry Date: 31-12-2021].
The manufacturer is informing users about an artefact visible prior to the use of the ID-Card that could be observed when using the ID-Antigen profile II batches mentioned above. The anti-k (KEL2) and anti-Kpa (KEL3) wells were observed to have a whitish deposit at the bottom of the well. The defect, present on all ID-cards of the batch 50380 29 01, can interfere with the automatic reading of reaction on IH-analyzers and readers (Saxo ID-Reader II, Banjo ID-Reader, IH-500 and IH-1000) and generate unexpected results for both positive and negative samples.
According to the manufacturer, when typing of k and Kpa antigens with the affected lot, there is a risk of uninterpretable or false positive results.
Affected users are advised to assess this situation with their biologist to determine if retesting is deemed necessary and take the appropriate course of action depending on the patient’s clinical conditions, medical history, and other relevant laboratory data. Affected users should stop using the ID-Cards «ID-Antigen Profile II» from lot number 50380 29 01 and discard those not used yet. They should use another batch of "ID-Antigen Profile II” or other ID-Cards intended for the k and Kpa antigen typing as:
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 20 Jul 2021