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Elecsys PTH
Roche Diagnostics GmbH · Model 08928428190 · UDI-DI 07613336170304
CEW
Prescription
1
510(k) clearances
1,479
Adverse events
21
Recalls
36
Facilities
Description
E2G 300 count
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-22 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using spec |
| 2024-11-26 | Beckman Coulter, Inc. | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below s |
| 2024-11-08 | Beckman Coulter Inc. | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before per |
| 2022-12-06 | Future Diagnostics Solutions B.V. | Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. |
| 2022-11-17 | Ortho-Clinical Diagnostics, Inc. | Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results |
| 2020-11-23 | Diasorin Inc. | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. |
| 2016-11-22 | Siemens Healthcare Diagnostics, Inc. | Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE 2000 |
| 2016-10-26 | Diagnostic Hybrids, Inc. | There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay. |
| 2016-10-05 | ORTHO-CLINICAL DIAGNOSTICS | The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that t |
| 2013-08-16 | Siemens Healthcare Diagnostics, Inc | PTH Calibrator packaged with only high calibrator. |
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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.