| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00610-1 |
| Product Name/Description |
IRISpec CA/CB/CC. An in vitro diagnostic medical device (IVD).
REF: 800-7702
Lot: 432-24 and higher
Expiry: 31 July 2024 and later
ARTG 200017
(Beckman Coulter Australia Pty Ltd - Clinical chemistry biological screening IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB glucose control failure, resulting in false positive results when used in conjunction with iChemVELOCITY Urine Chemistry Strips PNs 800-7204 and 800-7212.
If a QC run fails, the system will not allow the operator to run patient samples, causing a potential delay in patient results. The QC run should be repeated and pass successfully before running patient samples.
This problem affects IRISpec CB control lot numbers 432-24 and higher when analysed with iChemVELOCITY Urine Chemistry Strips PN 800-7204 lot numbers 7204661M and higher; and 800-7212 lot numbers 7212706M and higher. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Beckman Coulter has updated its control ranges to move the negative Glucose control from IRISpec CB to IRISpec CC. Customers are to update the CB and CC control ranges for Glucose, instructions on how to complete this are provided in the customer letter.
The updated Glucose ranges supersede the ranges listed in the IRISpec CB control Instructions for Use (IFU) PN C36362.AC, C36361.AC and the assay sheet C39722.AC and C39721.AC. Use only the specifications in the customer letter.
No retrospective review of QC or patient sample results is necessary.
A further investigation is taking place to prevent the re-occurrence of this problem. Customers will be provided more information when available. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |