Dimension EXL Tnih Calibrator
LOCI High-Sensitivity Troponin Calibrator
1manufacturer
1catalogue number
11510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-10-16 |
| Record revised | 2021-11-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -25 to -15 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10719483 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Laboratories | 15 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
Showing 12 of 391. All products under Calibrator, Secondary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162538 | 2016-11-17 |
| K130698 | 2013-04-05 |
| K113373 | 2011-12-30 |
| K103548 | 2011-06-02 |
| K110169 | 2011-04-07 |
| K103836 | 2011-02-16 |
| K083462 | 2009-02-27 |
| K082680 | 2008-10-10 |
| K081789 | 2008-09-10 |
| K081319 | 2008-08-04 |
| K081683 | 2008-07-07 |
Recalls
14 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-07-25 | Class II | Under Investigation by firm | There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on AD | 3067 units | |
| 2020-09-22 | Class II | Device Design | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results ma | US: 23 units; OUS: 204 units | |
| 2020-09-22 | Class II | Device Design | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results ma | US: 28; OUS: 255 units | |
| 2018-09-26 | Class II | Software design | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime | 217 units | 2020-06-24 |
| 2018-09-26 | Class II | Software design | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime | 490 units | 2020-06-24 |
| 2018-09-26 | Class II | Software design | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime | 410 units | 2020-06-24 |
| 2018-09-26 | Class II | Software design | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime | 264 | 2020-06-24 |
| 2017-04-05 | Class II | Nonconforming Material/Component | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per | 2019-04-02 | |
| 2016-05-05 | Class III | Under Investigation by firm | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in | 24,940.00 | 2018-02-02 |
| 2014-11-24 | Class II | Under Investigation by firm | Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the | 1230 | 2016-12-13 |
| 2014-08-28 | Class II | Process design | Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. | 6562 | 2015-03-30 |
| 2013-09-17 | Class II | Process control | Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration. | 1625 | 2014-08-27 |
| 2013-06-05 | Class II | Material/Component Contamination | Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-l | 7,470 | 2015-03-18 |
| 2013-05-14 | Class II | No Marketing Application | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | 99 (2 pk) | 2015-03-05 |
| 2013-05-14 | Class II | No Marketing Application | iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | 198 (6 pk) | 2015-03-05 |
| 2012-10-10 | Class III | Nonconforming Material/Component | Correlation slope bias and accuracy shift | 1985 cartons | 2014-01-08 |
| 2011-11-17 | Not classified | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients. | 2281 cartons | 2014-08-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.