| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00477-1 |
| Product Name/Description |
iChemVELOCITY Automated Urine Chemistry Systems equipped with Colour/Clarity/Specific Gravity Module. An in vitro diagnostic medical device (IVD)
System Reference Numbers: 800-3564, 800-7100, 800-7103, 800-7162, 800-7163, 800-7166, 800-3061
Colour/Clarity/Specific Gravity Module Reference Numbers; 700-7602, 700-7611, B93997
ARTG Number: 181116 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The iChemVELOCITY Colour/Clarity/Specific Gravity Module (CGM) detects and reports 11 colours as opposed to the 18 listed in the iChemVELOCITY Operator’s Manual. If the iChemVELOCITY Automated Urine Chemistry System is equipped with any of the affected CGM part numbers, the following urine colours will be detected and correctly reported: colourless, straw, light yellow, yellow, dark yellow, light amber, amber, dark amber, red, blue, and green. The following urine colours will not be detected or reported: orange, light brown, brown, dark brown, light red, dark red, other. There may be a discordance between the colour of the urine that is visually apparent and the colour that is reported, for the affected colours. In a worst case scenario, a discordant urine colour might prompt an additional non-invasive workup such as a repeat urinalysis or further testing. The results from the urine chemistry and microscopy will still be correctly reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users that the iChemVELOCITY Operator’s Manual will be updated to reflect colours that can be detected and reported by the affected CGMs. Furthermore, if the urine colour orange, light brown, brown, dark brown, light red, dark red or other colour than those listed as ‘can be detected and reported’ is visually observed during processing, it is recommended that users:
- Consider reporting the visually observed colour reading using the laboratory’s reporting system (e.g. hardcopy, LIS).
- Consider using an approved back-up analyser to process and report these samples if the colours above are needed within the laboratory.
This action has been closed out on 11/10/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |