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Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)
Medicalsystem Biotechnology Co., Ltd. · Model None · UDI-DI 06970291985185
10
510(k) clearances
113
Adverse events
8
Recalls
42
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-11 | Randox Laboratories Ltd. | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additi |
| 2020-08-11 | Randox Laboratories Ltd. | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX Instruments. Additi |
| 2018-10-11 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cu |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirm |
| 2015-05-07 | Roche Diagnostics Operations, Inc. | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2011-07-08 | Medtest Holdings, Inc. | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. |
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