| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01539-1 |
| Product Name/Description |
Haemoglobin A1c (HbA1c) Reagent. An in vitro medical device.
List Number: 4P52-21
Multiple Lot Numbers
ARTG: 185778 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified Foetal Haemoglobin (HbF) interference occurs at a level lower than what is stated in the HbA1c reagent package insert. The package insert states that the HbA1c assay is susceptible to interference effects from HbF at > 20%, while the most current data shows interference from HbF at > 5%. HbA1c results are invalid for patients with abnormal amounts of HbF, including those with known Hereditary persistence of Foetal haemoglobin. In healthy adults, approximately 95% of Hb is HbA, with small amounts (<3.5%) of HbA2 and HbF present. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is advising customers to be aware that falsely depressed results could occur when the HbF variant level in patient samples in >5%. Additional updates to the HbA1c reagent package insert will be provided to users once available.
This action has been closed out on 19/11/2018 |
| Contact Information |
1800 816 696 - Abbott Diagnostics |