Saliva Control
MassCheck® Cortisol, Cortisone, Saliva Control Level II
1manufacturer
4catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Chromsystems Instruments & Chemicals Gmbh, Germany |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-21 |
| Record revised | 2023-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -18 °C |
| Packaging | Pack of 5 |
| Distribution end date | 2023-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0354 | 5 x 1ml | In distribution |
| 0353 | 5 x 1ml | In distribution |
| 0349 | 5 x 1ml | Withdrawn |
| 0350 | 5 x 1ml | Withdrawn |
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 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-05-19 | Class II | Labeling Change Control | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | 1457 units | 2024-05-15 |
| 2022-05-19 | Class II | Labeling Change Control | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | 1330 units | 2024-05-15 |
| 2020-11-02 | Class II | Under Investigation by firm | XXX | 342 vials | 2021-12-20 |
| 2020-11-02 | Class II | Under Investigation by firm | XXX | 363 vials | 2021-12-20 |
| 2020-11-02 | Class II | Under Investigation by firm | Products do not meet stability criteria and may impact results. | 362 vials | 2021-12-20 |
| 2020-10-29 | Class II | Under Investigation by firm | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | 880 vials | |
| 2020-10-29 | Class II | Under Investigation by firm | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | 850 vials |
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.