| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00562-1 |
| Product Name/Description |
ARCHITECT Free T4 Reagent. An in vitro diagnostic medical device (IVD)
List Numbers: 7K65-29 (100 Test Kit), 7K65-34 (2000 Test Kit) and 7K65-39 (500 Test Kit)
Multiple Lot Numbers
ARTG Number: 180112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diagnostics is providing information regarding a change of measuring interval for the ARCHITECT Free T4 assay list numbers 7K65-29, 7K65-34 and 7K65-39.
The current measuring interval is 0.40 ng/dL (5.15 pmol/L) to 6.00 ng/dL (77.22 pmol/L).
Recent data generated by Abbott have determined that the measuring interval is 0.40 ng/dL (5.15 pmol/L) to 5.00 ng/dL (64.35 pmol/L). This new measuring range will be included in a future version of the instructions for use and the new FT4 assay file.
There is no impact to patient results with values between 0.40 ng/dl (5.15 pmol/L) and 5.0 ng/dl (64.35 pmol/L). Only the measuring interval between 5.00 – 6.00 ng/dL (64.35 – 77.22 pmol/L) is affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott is advising users that patient sample results between 5.00 ng/dL (64.35 pmol/L) and 6.00 ng/dL (77.22pmol/L) should be reported as >5.00 ng/dL (64.35pmol/L). In addition, the customer letter should be reviewed with the laboratory’s management for potential impact specific to laboratory procedures such as internal ranges.
This action has been closed out on 08/08/2019 |
| Contact Information |
1800 816 696 - Abbott Customer Support |