| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00679-1 |
| Product Name/Description |
Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor Immunoassays. An in vitro diagnostic medical device (IVD)
(for use with the Access family of immunoassay systems)
Access Total 3
Reference Number: 33830
Access Thyroglobulin
Reference Number: 33860
Access Free T4
Reference Number: 33880
Access GI Monitor
Reference Number: 387687
All Lots
ARTG Numbers: 213975 and 213976 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined through customer feedback and an internal investigation that the four (4) Access immunoassays listed are susceptible to biotin interference. During interference testing, the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population.
Specimens from patients who are undergoing biotin therapy and/or ingesting biotin supplements may contain high levels of biotin. The higher biotin concentration in these specimens interferes with the biotin-streptavidin assay design of these four affected Access assays and may cause false low results (for the Access GI Monitor and Thyroglobulin assays) and false high results (for the Access Free T4 and Total T3 assays). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter will update the "Limitations" section of the Access Total T3, Thyroglobulin, Free T4, and GI Monitor Instructions for Use with this biotin interference information. Users are requested to interpret the results in light of the total clinical presentation of the patient (including symptoms, clinical history, data from additional tests, and other appropriate information).
This action has been closed out on 31/10/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Technical Support Centre |