Home › RANDOX LABORATORIES LIMITED › LDH
LDH
RANDOX LABORATORIES LIMITED · Model LD2812 · UDI-DI 05055273204100
CFJ
Prescription
1
510(k) clearances
113
Adverse events
8
Recalls
42
Facilities
Description
The LDH method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of lactate dehydrogenase activity in serum or plasma.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.