SP CAL (LIQ)
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM,…
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, RF and Transferrin assays.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
5510(k) clearances naming this product code
10recalls 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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| 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, Manufacturer |
| 510(k) | K031608 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Open vials are stable for 30 days in the absence of bacterial contamination. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IT2692 | In distribution | |
| IT2691 | 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 |
|---|---|
| K061056 | 2006-07-20 |
| K053153 | 2006-01-13 |
| K031608 | 2003-08-08 |
| K023158 | 2002-10-24 |
| K955489 | 1996-06-21 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 2024-03-01 | Class II | Under Investigation by firm | The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. | 1,764 units | |
| Randox Laboratories Limited | 510(k) number | 2023-07-19 | Class II | Under Investigation by firm | As part of the firm’s ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2 | 166 units | |
| Randox Laboratories Limited | 510(k) number | 2019-08-09 | Class II | Nonconforming Material/Component | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material. | 100 kits | 2021-01-08 |
| Randox Laboratories Limited | 510(k) number | 2018-11-19 | Class II | Under Investigation by firm | Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. | 250 kits (32 kits US / 218 kits OUS) | 2020-04-23 |
Recalls
5 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. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-03-05 | Class II | Process design | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods. | 80,366 units (US: 242 units; OUS: 80,094 units) | |
| 2023-11-20 | Class II | Under Investigation by firm | CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%. | 269 kits | |
| 2023-11-20 | Class II | Under Investigation by firm | Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples | 108 kits | |
| 2023-11-13 | Class II | Under Investigation by firm | There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 | ||
| 2021-03-29 | Class II | Nonconforming Material/Component | Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator an | 98 kits | 2021-11-22 |
| 2019-07-12 | Class III | Under Investigation by firm | Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards). | 307 kits | 2020-06-17 |
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.