| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01420-1 |
| Product Name/Description |
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100
Multiple Part Numbers
ARTG Number: 181116 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Iris International has determined that the iQ200 Series Urine Microscopy Analyser with Barcode Reader (Model NFT-2100), may intermittently exhibit the following:
? Failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor.
? Failure to read body fluid dilution barcode label where the rack is rejected and no results are generated.
When the iQ Series Analyzer fails to read the urine sample dilution barcode label, erroneous results with incorrect concentrations and inaccurate particle counts for any formed particles will be generated.
? Incorrect patient results will be observed as an unexpected discrepancy between instrument results and the patient's clinical picture.
? The greatest impact could be a delay in recognition of Hematuria. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is working on a resolution to correct and prevent recurrence of this issue. Until then, anytime a dilution has been made, the laboratory must verify that the dilution factor is correct before release of final results.
If Auto-Release is used, the printing option should always be enabled for result release and the printout verified.
If Auto-Release is not used, verify that the dilution factor is correct on the specimen screen and if thedilution factor is incorrect, delete results and create a manual order for the specimen with the correct dilution factor.
Users are requested to share this information with staff and retain this notification as part of laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter.
Advise Beckman Coutler within 10 days of receiving this notice as directed.
This action has been closed out on 17/11/2020 |
| Contact Information |
1800 060 881 - Customer Support Centre |