ImmunoDOT Thyroid Positive Control
GenBio · Model 800-3912 · UDI-DI 00613745039121
10
510(k) clearances
15
Adverse events
4
Recalls
13
Facilities
Description
Thyroid Positive Control contains antibodies specific to human thyroid peroxidase (TPO, microsome) and human thyroglobulin. This control is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.