i-STAT
CAL.VERIF. SET (4ea,5lvlx1.7ml ampules/bx)
1manufacturer
24catalogue numbers in this listing
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 | Abbott Point OF Care 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K972868 |
| Record published | 2023-06-23 |
| Record revised | 2024-06-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 06P17-05 | 6 | In distribution | |
| 06F13-01 | 10 | In distribution | |
| 06P17-06 | 6 | In distribution | |
| 06P17-08 | 6 | In distribution | |
| 06F14-01 | 10 | In distribution | |
| 05P71-01 | 10 | In distribution | |
| 06P17-26 | In distribution | ||
| 06P17-12 | 6 | In distribution | |
| 05P70-01 | 20 | In distribution | |
| 06P17-10 | 6 | In distribution | |
| 05P73-01 | 10 | In distribution | |
| 06P17-02 | 6 | In distribution | |
| 06P17-09 | 6 | In distribution | |
| 06P17-11 | 6 | In distribution | |
| 06P17-25 | In distribution | ||
| 06F15-01 | 20 | In distribution | |
| 06P17-07 | 6 | In distribution | |
| 06F12-14 | 10 | In distribution | |
| 06P17-01 | 6 | In distribution | |
| 06F12-01 | 10 | In distribution | |
| 06P17-04 | 6 | In distribution | |
| 06P17-24 | In distribution | ||
| 05P72-01 | 10 | In distribution | |
| 06P17-03 | 6 | 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 |
| 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 |
| Rap/Tac/CsA Control | More Diagnostics Inc. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2024-01-09 | Class II | Storage | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 – 46.4 Degrees Fahrenheit (2 – 8 Degrees Celsius) for up to 60 minute | 1 unit |
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2024-01-09 | Class II | Storage | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 – 46.4 Degrees Fahrenheit (2 – 8 Degrees Celsius) for up to 60 minute | 2 units |
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 |
|---|---|---|---|---|---|
| 2010-08-03 | Not classified | Other | Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types. | 8293 Value sheets worldwide | 2011-09-28 |
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.