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Teco Diagnostics Iron Reagent Kit for TC Matrix
TECO DIAGNOSTICS · Model I592-380TM · UDI-DI 10673486002003
JIY
Prescription
1
510(k) clearances
55
Adverse events
19
Recalls
36
Facilities
Description
Teco Diagnostics Iron Reagent Kit for TC Matrix is used for the quantitative determination of iron concentration in serum on TC Matrix analyzers.
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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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.