ImmunoDOT Thyroid Autoimmunity Panel
GenBio · Model 800-5825 · UDI-DI 00613745058252
10
510(k) clearances
15
Adverse events
4
Recalls
13
Facilities
Description
The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-05 | Beckman Coulter, Inc. | IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. |
| 2019-04-30 | Beckman Coulter Inc. | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422 |
| 2011-01-26 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers id |
| 2010-06-29 | Beckman Coulter Inc. | The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits. |
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