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Pointe Scientific, Inc. Total Protein
HORIBA INSTRUMENTS INCORPORATED · Model HT928-576 · UDI-DI 00811727013101
CEK
Prescription
1
510(k) clearances
93
Adverse events
10
Recalls
44
Facilities
Description
Total Protein Reagent is for the quantitative determination of total protein concentration in serum on Hitachi analyzers. For in vitro diagnostic use only. 6 x 66ml, 6 x 30ml.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-11 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. |
| 2024-07-29 | Siemens Healthcare Diagnostics, Inc. | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2024-07-29 | Siemens Healthcare Diagnostics, Inc. | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. |
| 2023-01-27 | Siemens Healthcare Diagnostics, Inc. | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results |
| 2021-09-20 | Siemens Healthcare Diagnostics, Inc. | The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsel |
| 2021-09-20 | Siemens Healthcare Diagnostics, Inc. | The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely de |
| 2020-12-15 | Ortho Clinical Diagnostics Inc | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides |
| 2020-12-15 | Ortho Clinical Diagnostics Inc | Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides |
| 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. |
| 2003-03-26 | Ortho-Clinical Diagnostics | Slides may exhibit random, elevated imprecision of results. |
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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.