RAPIDPoint® 405/500 Measurement Cartridge
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to…
RAPIDPoint® 405/500 Measurement Cartridge (400 tests) – pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GKR |
| Device type | System, Hemoglobin, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5620 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K020616 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | expiry date, serial number |
| Storage | Handling environment temperature 2 to 25 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10327073 | In distribution | |
| 10313971 | In distribution | |
| 10844811 | In distribution | |
| 10283222 | In distribution | |
| 10844812 | In distribution | |
| 10323175 | In distribution | |
| 10283221 | In distribution | |
| 10310469 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| HemoCue® Hb 301 Microcuvettes | Hemocue AB | 5 |
| HemoCue® Hb 201 Microcuvettes | Hemocue AB | 4 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Mission Plus Hemoglobin (Hb) Monitoring System | Acon Laboratories, Inc. | 3 |
| Mission Plus Hemoglobin (Hb) Test Cartridges | Acon Laboratories, Inc. | 3 |
| DiaSpect Tm | EKF Diagnostic Gmbh | 2 |
| HemoCue® Hb 201+ Analyzer | Hemocue AB | 2 |
| Mission Capillary Transfer Tubes | Acon Laboratories, Inc. | 2 |
| Mission Plus Hemoglobin (Hb) Optical Verifier | Acon Laboratories, Inc. | 2 |
| HemoCue® Hb301 Analyzer | Hemocue AB | 2 |
| HemoCue® Hb 201 DM Analyzer | Hemocue AB | 2 |
Showing 12 of 43. All products under System, Hemoglobin, Automated
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 | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 2248 | 2020-06-23 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 10199 | 2020-06-23 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 138 | 2020-06-23 |
| 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 2357 | 2020-06-23 |
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.