BioPlex 2200
BioPlex 2200 Syphilis Total & RPR Calibrator Lot Data
1manufacturer
8catalogue numbers in this listing
1recall
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 | Bio-Rad Laboratories 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 |
| 510(k) | K183446 |
| Record published | 2016-09-12 |
| Record revised | 2021-07-29 (version 7) |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 0.5 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6633720 | 1 Each | In distribution |
| 12006552 | Total Volume 0.5 ml | In distribution |
| 12000877 | 3 Vials | In distribution |
| 12000652 | 1 Each | In distribution |
| 12000651 | Total Volume 0.5 ml | In distribution |
| 6633700 | Total Volume 0.5 ml | In distribution |
| 12000878 | 1 Each | In distribution |
| 12006553 | 1 Each | 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 |
| AU | Beckman Coulter, Inc. | 6 |
| Fluid Pack | Diamond Diagnostics Inc. | 5 |
Showing 12 of 391. All products under Calibrator, Secondary
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | UDI-DI | 2022-02-08 | Class II | Under Investigation by firm | Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability | 724 Calibrator sets (U.S.) |
| Bio-Rad Laboratories Inc. | UDI-DI | 2021-09-17 | Class II | Nonconforming Material/Component | Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vacc | 791 units |
| Bio-Rad Laboratories Inc. | UDI-DI | 2020-04-21 | Class II | Unknown/Undetermined by firm | The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. | 12000 kits |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-11-17 | Not classified | Other | The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results. | 900 kits, 43 sets distributed. | 2007-11-28 |
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.