| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01422-1 |
| Product Name/Description |
iChemVELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)
Lot Number: 7204170 A
Serial Number: 10500 through 12818
ARTG Number: 177551 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Iris International has become aware of a strip manufacturing error where an incorrect pad was inadvertently placed in the location of the compensation pad. All the other analytes are correct.
This defect exists on a subset of vials belonging to Lot 7204170 A with the serial numbers of the impacted vials ranging from 10500 through 12818.
Beckman Coulter is working on a resolution to prevent recurrence of this issue.
This action is being taken following consultation with the Therapeutic Goods Administration. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Inspect any remaining inventory to determine if you have the impacted vials
The vial serial number is located on the bottom of the vial beneath the lot number.
2. Discard any remaining impacted vials.
3. Contact your local support representative for product replacement.
4. Consult with your Laboratory Director to determine if a retrospective review of results is clinically warranted.
5. Share this information with your laboratory staff and retain this notification. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.
6. Complete and return the supplied Response Form within 10 days so Beckman Coutler can be assured you have received this communication.
This action has been closed out on the 26/11/2018. |
| Contact Information |
1800 060 881 - Customer Support Centre |