AU
Serum Protein Multi-Calibrator 2
3manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
4recalls 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 | Beckman Coulter, 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, Manufacturer, Exporter |
| 510(k) | K033910 |
| Record published | 2016-09-24 |
| Record revised | 2020-12-21 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DR0090 | In distribution | |
| ODR3023 | In distribution | |
| ODR3021 | In distribution | |
| DR0091 | 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 |
|---|---|
| K110251 | 2011-05-25 |
| K032287 | 2003-08-18 |
| K984014 | 1998-12-23 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2017-08-24 | Class II | Under Investigation by firm | Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired | unknown | 2020-08-28 |
| 2017-05-15 | Class II | Nonconforming Material/Component | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1. | 4444 AQUA CAL Level 1 kits | 2020-09-09 |
| 2011-12-15 | Class III | Labeling mix-ups | The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes. | 5746 units total (2729 units in US) | 2012-12-28 |
| 2004-07-29 | Not classified | Other | incorrect Calibration Acceptance Limits. | 771 | 2005-02-03 |
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.