| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00321-1 |
| Product Name/Description |
DiaClon ABO/D+ Reverse Grouping for Patients. An in vitro diagnostic medical device (IVD).
Catalogue Number: 001267
Displayed Lot Number: 50093 87 17
SAP Lot Number: 2201808717
Expiry Date: 31/01/2019
ARTG Number: 212527
(Bio-Rad Laboratories Pty Ltd - Multiple blood grouping and typing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad have been made aware that a limited amount of ID-Cards DiaClon ABO/D + Reverse Grouping for Patients, lot 50093 87 17, were packed in boxes stating a storage temperature range of 2-8°C on the outer carton instead of 18-25°C for this product.
The product label shows the correct storage conditions for this product. This issue has no impact on product used prior to May 1 2018. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Bio-Rad is advising users to inspect their inventory to confirm that the affected lot has been stored between 18-25°C and not 2-8°C. If for any reason the product is stored at 2-8°C, please discard product after 1st May 2018.
This action has been closed out on the 15/11/2018. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |