Atellica CH LSP Calibrator
Liquid Specific Protein (LSP) Calibrator Atellica CH - CAL 6 x 1 x 1.0mL
3manufacturers in China registered for this device type
1catalogue number
12510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K103701 |
| Record published | 2017-12-27 |
| Record revised | 2021-11-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11099434 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153365 | 2015-12-18 |
| K140790 | 2015-06-15 |
| K123321 | 2013-02-15 |
| K122398 | 2012-10-12 |
| K103701 | 2011-02-18 |
| K103612 | 2011-01-25 |
| K101460 | 2010-07-09 |
| K100778 | 2010-05-05 |
| K093732 | 2010-03-22 |
| K093645 | 2010-03-05 |
| K083579 | 2009-02-20 |
| K081103 | 2008-05-23 |
Recalls
16 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 |
|---|---|---|---|---|---|
| 2023-10-26 | Class II | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary inter | 6611 cartridges US | |
| 2023-10-26 | Class II | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary inter | 6035 cartridges US | |
| 2023-10-26 | Class II | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary inter | 3505 Cartridges US | |
| 2023-10-26 | Class II | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary inter | 0 cartridges US | |
| 2019-11-19 | Class II | No Marketing Application | Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery. | 844 | 2021-08-30 |
| 2019-11-19 | Class II | No Marketing Application | Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica CH Analyzer. | 1306 | 2021-08-30 |
| 2017-11-09 | Class II | Under Investigation by firm | An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay. | 989 (681 USA/308 OUS) | 2020-06-08 |
| 2016-09-15 | Class II | Under Investigation by firm | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082. | 9,935 units | 2018-05-31 |
| 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 Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 1 | 13,147 units | 2018-02-02 |
| 2016-02-04 | Class II | Under Investigation by firm | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 519 pack | 2017-08-01 |
| 2016-02-04 | Class II | Under Investigation by firm | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 15224 (2-pack) | 2017-08-01 |
| 2016-02-04 | Class II | Under Investigation by firm | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 6455 (6 pack) | 2017-08-01 |
| 2015-01-19 | Class II | Device Design | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value misca | 657 | 2015-09-21 |
| 2014-09-26 | Class II | Device Design | Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. | Total = 19,352 (13,881 – 2 pack, 4878 – 6 pack, 593 – 6 pack | 2016-01-29 |
| 2014-08-18 | Class II | Process design | Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens conf | 9769 Total (6000 US) | 2015-02-02 |
| 2014-08-06 | Class II | Software design | The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detecte | Domestic: 1122 kits; Foreign: 236 kits | 2017-02-28 |
| 2014-01-06 | Class II | Nonconforming Material/Component | Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL). | 3496 | 2015-05-06 |
| 2010-02-26 | Not classified | Employee error | There is incorrect barcode information, which can potentially cause the Alert Message “Calibrator Insert Missing” to be displayed. | 1310 cartons | 2010-10-13 |
| 2009-10-23 | Not classified | Other | patient results are depressed | 1753 cartons | 2010-06-22 |
| 2009-08-31 | Not classified | Other | Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001. | 1474 Cartons | 2010-12-13 |
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.