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Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
FDA product code CFJ · Class 2 · Clinical Chemistry
117
Registered devices
113
Adverse events
8
Recalls
111
510(k) clearances
Devices with this code
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.LDH Liqui-UV® — STANBIO LABORATORY, L.P.LDH Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method) — Medicalsystem Biotechnology Co., Ltd.Atellica CH Lac — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Lactate dehydrogenase liquid acc to IFCC — Roche Diagnostics GmbHADVIA® Chemistry LAC Lactate Reagents — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix — TECO DIAGNOSTICSLDH — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Lactate Dehydrogenase acc. to IFCC ver.2 — Roche Diagnostics GmbHTeco Diagnostics LDH-L Reagent Set — TECO DIAGNOSTICSPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDADVIA® Chemistry LDPL Reagents — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® CLC720 LDH RGT KIT Product No. ST205 — CAROLINA LIQUID CHEMISTRIES CORPORATIONMedTest DX Lactate Dehydrogenase / BS480 — Medtest Dx, Inc.ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATED
Recent 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 |
| 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 |
| 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 assa |
| 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 |
| 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. |
| 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 |
| 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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