| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00990-1 |
| Product Name/Description |
Calibration Serum Level 3 and Human Assayed Multi-Sera Level 2 and Level 3. An in vitro diagnostic medical device (IVD)
Calibration Serum Level 3
Catalogue number: CAL2351
Multiple lot numbers
Human Assayed Multi-Sera Level 2 and Level 3
Catalogue number: HN1530 and HE1532
Multiple lot numbers
ARTG 204567 & 207886 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
The following three issues have been identified by Randox:
1. There have been transcription errors in the instructions for Instructions for Use (IFU) for the calibration serum level 3, CAL2351. Additionally, standardisation, is off by 13% to the reference material for CK-NAC.
2. The target for Alkaline Phosphatase (ALP) for the AMP optimised to IFC 37oC method has been mis-assigned for the RX series instruments in calibration serum level 3, CAL2351, lot 1214UE by approximately 10%.
3. There are additional target values present for Direct Bilirubin in CAL2351 lot 1262UE and Triglycerides in CAL2351 lot 1260UE and 1315UE which are incorrect. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised of the following for each issue:
1. Review any results generated and discuss with the Medical Director if RX Series targets for CK Total has been used. Target values have been reassigned. Discard all old copies of the IFU and download the new version from the Randox website. (Product Defect Correction)
2. Review any results generated and to contact Randox technical services if they are using the affected lot for Alkaline Phosphatase (ALP) for the AMP method on RX instruments.Review calibrator inventory of the affected lot and assess the laboratories' needs for reimbursement for discarded inventory. (Recall)
3. Discuss with their laboratories' Medical Director if y the incorrect target value has been used for either Direct Bilirubin in CAL2351 lot 1262UE or Triglycerides in lots 1260UE or 1315UE. Discard all copies of the IFUs and download the latest versions from the Randox website. (Product Defect Correction) |
| Contact Information |
02 9615 4640 - Randox Technical Services |