BioPlex 2200
HSV-1 & HSV-2 Control Lot Data
1manufacturer
16catalogue numbers in this listing
26510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 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 |
| 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 to 1.5 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6631430 | Total Volume 1.5 ml | In distribution |
| 6633230 | Total Volume 1.5 ml | In distribution |
| 6631141 | 1 Each | In distribution |
| 6631840 | 1 Each | In distribution |
| 6631240 | 1 Each | In distribution |
| 6631340 | 1 Each | In distribution |
| 6633330 | 4 Vials | In distribution |
| 6631630 | 6 Vials | In distribution |
| 6631330 | 4 Vials | In distribution |
| 6631640 | 1 Each | In distribution |
| 6631230 | 4 Vials | In distribution |
| 6631830 | 4 Vials | In distribution |
| 6631440 | 1 Each | In distribution |
| 6631131 | 6 Vials | In distribution |
| 6633200 | Total Volume 0.5 ml | In distribution |
| 6633340 | 1 Each | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
| Rap/Tac/CsA Control | More Diagnostics Inc. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163015 | 2017-01-10 |
| K150300 | 2015-12-11 |
| K143379 | 2015-03-13 |
| K141073 | 2014-06-23 |
| K140916 | 2014-05-06 |
| K140764 | 2014-04-25 |
| K134013 | 2014-04-24 |
| K133960 | 2014-01-22 |
| K132227 | 2013-10-25 |
| K130963 | 2013-05-06 |
| K130761 | 2013-04-12 |
| K130162 | 2013-03-01 |
| K123775 | 2013-01-31 |
| K123663 | 2012-12-27 |
| K123198 | 2012-11-20 |
| K122838 | 2012-10-17 |
| K082036 | 2008-09-08 |
| K073080 | 2008-01-24 |
| K071675 | 2007-07-03 |
| K043108 | 2004-12-07 |
| K042335 | 2004-09-17 |
| K040822 | 2004-05-19 |
| K040277 | 2004-03-10 |
| K040273 | 2004-03-04 |
| K022041 | 2002-07-16 |
| K020817 | 2002-04-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | UDI-DI | 2023-02-21 | Class II | Under Investigation by firm | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad | 225 units |
Recalls
1 of these is Class III. 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 |
|---|---|---|---|---|---|
| 2013-04-15 | Class III | Material/Component Contamination | The Liquichek” ToRCH Plus IgM Control – Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product. | 211 boxes and 5 MiniPaks | 2013-08-01 |
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.