Dimension® Flex® Reagent Cartridge LA
Lactic Acid Flex® reagent cartridge, 120 tests
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
7recalls on this code
Who Else Makes It
Concentrated in Shandong (1), Hunan (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | KHP |
| Device type | Acid, Lactic, Enzymatic Method |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1450 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K914508 |
| Record published | 2020-09-24 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10444961 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StatSensor/StatStrip | Nova Biomedical Corporation | 5 |
| Stat Profile | Nova Biomedical Corporation | 5 |
| Lactate Gen.2 | Roche Diagnostics Gmbh | 4 |
| Lactate Plus | Nova Biomedical Corporation | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| i-STAT | Abbott Point OF Care Inc. | 3 |
| Alinity | Abbott Medical | 2 |
| Fora | Fora Care Inc. | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| LA Cartridge | LifeHealth, LLC | 2 |
| L-Lactate (LAC) | Randox Laboratories Limited | 2 |
| ABX Pentra Lactic Acid | Horiba ABX SAS | 1 |
Showing 12 of 43. All products under Acid, Lactic, Enzymatic Method
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113216 | 2012-05-03 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. 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 |
|---|---|---|---|---|---|
| 2016-07-05 | Class III | Under Investigation by firm | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States | 76 | 2017-08-02 |
| 2015-08-24 | Class II | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | 2079 cartridges | 2016-05-23 |
| 2015-08-24 | Class II | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | 49 cartridges | 2016-05-23 |
| 2015-08-24 | Class II | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | 982 cartridges | 2016-05-23 |
| 2015-08-24 | Class II | Process control | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | 1213 cartridges | 2016-05-23 |
| 2015-07-28 | Class II | Software design | When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing | 5241 units | 2017-02-17 |
| 2014-05-23 | Class II | Process design | RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) | 20,507 cartridges | 2015-06-10 |
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.