| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00997-1 |
| Product Name/Description |
UTAK Validity Control 2 and 3
UTAK Validity Control 2
Lot Number: C8933, D1950
Unique Device Identification (UDI): 00630414974750C893320231130, 00630414974750D195020240930
Expiry Date: 30/11/2023, 30/09/2024
UTAK Validity Control 3
Lot Number: 10445226
Unique Device Identification (UDI): 00630414979984D182120240831
Expiry Date: 31-08/2024
ARTG 279922
(Siemens Healthcare Pty Ltd - Clinical chemistry toxicology/drug detection IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
UTAK has received reports from customers regarding the discovery of particulate matter in certain Validity Control 2 and 3 lots. In response to the reports received, UTAK initiated an investigation and conducted independent third-party testing to identify the particulate matter.
The results of the microbial analysis are:
Test: Bacterial Culture-Counts with Identification
Results: Total Bacterial Count <10-CFU/ml-No Growth
UTAK's investigation has determined that this incident does not pose a health risk. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
UTAK has suggested particles do not appear to impact results but advised customers to discontinue use of these lots out of caution.
In the absence of an alternative lot number for 10445225 UTAK Validity Control 2, each customer should use their internal laboratory processes to determine the suitability of the QC material for their testing.
Customers should review their inventory of this product and assess their laboratory’s replacement needs.
This action has been closed out on 22/02/2024 |
| Contact Information |
1800 310 300 or Geoff Bain, Technical Manager Specialty Diagnostix on 0431 522 700 |