Home › Device types › JZO
System, Test, Thyroid Autoantibody
FDA product code JZO · Class 2 · Immunology
133
Registered devices
310
Adverse events
18
Recalls
92
510(k) clearances
Devices with this code
ANTI-THYROGLOBULIN TEST KIT (TgAb) — KRONUS, INC.ARCHITECT — Abbott Ireland DiagnosticsAIA-PACK TPOAb CALIBRATOR SET — TOSOH CORPORATIONAtellica IM Calibrator O — Siemens Healthcare Diagnostics Inc.Atellica IM aTPO QC — Siemens Healthcare Diagnostics Inc.ANTI-TG — ORGENTEC Diagnostika GmbHANTI-THYROGLOBULIN TEST KIT (TgAb) — KRONUS, INC.ADVIA Centaur® aTG MCM — Siemens Healthcare Diagnostics Inc.TSH Receptor Autoantibody ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT — KRONUS, INC.Thyretain — DIAGNOSTIC HYBRIDS, INC.IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) — KRONUS, INC.Thyretain — DIAGNOSTIC HYBRIDS, INC.MeDiCa — SCIMEDX CORPORATIONAtellica IM Calibrator 1 — Siemens Healthcare Diagnostics Inc.EliA anti-TPO Well — Phadia ABAtellica IM Anti-Thyroglobulin II (aTgII) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® Systems QC anti-TPO 1,2 — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsAnti TG Ab ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM aTPOII — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAIA-PACK TPOAb CONJUGATE — TOSOH CORPORATIONADVIA Centaur® Systems Calibrator 1 — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-21 | Roche Diagnostics Operations, Inc. | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as d |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-08-21 | Siemens Healthcare Diagnostics, Inc. | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM |
| 2024-08-21 | Siemens Healthcare Diagnostics, Inc. | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM |
| 2024-04-23 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. |
| 2024-04-23 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 |
| 2023-04-24 | Abbott Ireland Limited | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the In |
| 2022-08-11 | Siemens Healthcare Diagnostics, Inc. | An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there i |
| 2020-08-20 | Roche Diagnostics Operations, Inc. | Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. There |
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