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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model HT928-1200 · UDI-DI 00811727012777
CEK
Prescription
1
510(k) clearances
94
Adverse events
10
Recalls
43
Facilities
Description
Total Protein Reagent, for the quantitative determination of total protein concentration in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 8 x 100mL, 4 x 100mL
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 Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely de |
| 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 |
| 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.