Direct TIBC Reagent Set
CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model R1 x 90mL, R2 x 60mL · UDI-DI 00812137012104
Description
For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Total iron-binding capacity (TIBC) is the measure of the ability of serum proteins, principally transferrin, to bind iron. It is the maximum concentration of iron that the serum proteins can bind. Together with the total serum iron concentration, the TIBC is used in the diagnosis and treatment of iron deficiency anemia, other disorders of iron metabolism, and chronic inflammatory disorders. As an index of nutritional status, Serum TIBC is increased in iron deficiency, and decreased in anemia that is due to chronic disease.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-03-13 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positiv |
| 2023-09-29 | Sentinel CH SpA | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for |
| 2023-09-29 | Sentinel CH SpA | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for |
| 2022-06-28 | Siemens Healthcare Diagnostics, Inc. | Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately aft |
| 2016-08-25 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instruct |
| 2016-08-25 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instruct |
| 2016-07-20 | Sterling Diagnostics, Inc. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2012-10-08 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated w |
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