| TGA Action ID |
RC-2026-RN-00716-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ID-DiaCell I-II-III. An in vitro diagnostic medical device (IVD).
Catalogue Number: 004310
Batch/Lot Number: 133842941
IHD Display Batch: 45184.94.1
Expiry Date: 28/09/2026 |
| ARTG Number |
213161 |
| Unique Device Identifier (UDI) |
07611969000968 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Bio-Rad identified unexpected weak or borderline positive reactivity with Screening Cell III of ID-DiaCell I-II-III, Batch 133842941/45184.94.1.
The problem was initially identified during pre-acceptance testing. At some sites, the observed reactivity resulted in pre-acceptance testing failures, preventing the affected batch from being released for routine use. At other sites, the product passed laboratory QC; however, weak false positive reactivity of Screening Cell III was subsequently observed during routine use.
False positive antibody screening results may lead to unnecessary follow-up testing, delays in result availability or blood unit release, and potential discard of donor blood units. |
| Instructions for Customers/Users |
Customers are to:
- If a suspected non-specific reaction is identified during result validation, discontinue use of the affected product and discard any unused impacted units.
- Use an alternative lot of ID-DiaCell I-II-III from available stock.
- If no alternative lot is available, contact Bio-Rad to arrange replacement of the affected product. |
| Action Commencement Date |
22/09/2026 |
| Responsible Entity |
|
| Contact Information |
02 9914 2800 - Bio-Rad Laboratories |