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NOVA Lite® Thyroid
INOVA DIAGNOSTICS, INC. · Model 708350 · UDI-DI 08426950596240
JZO
Prescription
1
510(k) clearances
310
Adverse events
18
Recalls
34
Facilities
Description
1. 10x 8-well Thyroid Substrate Slides 2. 1x 7mL FITC IgG Conjugate Primate Absorbed 3. 1x 0.5 mL Thyroid Positive 4. 1x 0.5mL IFA Systems Negative Control 5. 1x 25mL PBS Concentrate (40x) 6. 1x 7mL Mounting Medium 7. 1x 10 Coverslips
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 delay of treatment or |
| 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 conditions. This failur |
| 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 conditions. This failur |
| 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 analyzer. |
| 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 analyzer. |
| 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 Anti-TG Ab. |
| 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 Instructions for Use ( |
| 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 is a potential for er |
| 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. Therefore, the claim has |
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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.