| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01642-1 |
| Product Name/Description |
Glucose GLUC-PAP. An in-vitro diagnostic medical device (IVD).
Catalogue Number: GL1021
GTIN: 05055273203165
Batch/Lot Number: 385671
Expiry Date: 28th Jan 2019
ARTG Number: 199617 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Randox confirms a transcription error when quoting the concentration in g/l for Glucose Standard Lot 2082GL. The correct value should state 0.98g/l.
The risk to health when this issue occurs is the potential for reporting incorrect elevated glucose results. However this is highly unlikely as Quality Control results would also be elevated by a factor of ten. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Randox is requesting users;
1. Replace the kit IFU with the correct revision as attached to the customer letter;
2. Discuss the contents of the notice with your Medical Director; and
3. Complete and return the vigilance response form provided.
This action has been closed out on 06/11/2018 |
| Contact Information |
02 9615 4640 - Randox Australia |