| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00549-1 |
| Product Name/Description |
DiaClon ABO/D + Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).
Catalog Number: 001265
Product UDI: 07611969071623
Batch/Lot (SAP): 9064294236
Batch/Lot (IHD): 50093 42 36
Updated:2/8/2024: ID-Card “DC-Screening II”, lot 9037054118
Multiple batches / lots affected
ARTG 212527, 217696, 217697, 220117, & 225037
(Bio-Rad Laboratories Pty Ltd - Multiple blood grouping and typing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
The anti-B microtube of the ID-Card “DiaClon ABO/D + Reverse Grouping for Patients”, lot 9064294236 may result in weak or even false negative reactions with B positive samples.
In the context of Transfusion, Transplantation (patient side), Haemolytic disease of the foetus and newborn (HDFN), and donor qualification, the risk of false negative result in the anti-B may have minor clinical impact. In the context of Transplantation (donor side), the risk of false negative result in anti-B microtube may have an intermediate clinical impact.
Update:2/8/2024 – BioRad is confirming a similar issue with the anti-C3d well of the ID-Card “DC-Screening II”, lot 9037054118. Weak to false negative reactions with C3d positive samples may occur. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1. Stop using the affected lots of the ID-Cards in the customer letter and destroy any cards that have not yet been used.
2. Switch to another available lot or arrange for procurement of an unaffected lot through Bio-Rad free of charge.
3. Assess the situation with the medical director to determine if retesting is deemed necessary and take the appropriate course of action depending on the medical context of use of the device, the patient/donor history, and other relevant laboratory data. |
| Contact Information |
1800 224 354 - Bio-Rad Technical Support |