Recall Z-0499-2019 ยท CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323
| Date | Oct 11, 2018 |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. |
| Root cause | Process control |
| Action | An Urgent Medical Device Correction were issued on October 11, 2018 to all Dimension Vista customers to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: -Configure Dimension Vista System to eliminate the potential for cuvette carryover from lactic acid. -If unable to separate the assays due to lack of additional server based on the the Dimension Vista model, run Lactate Dehydrogenase method in duplicates and contact Siemens if either result is discordant. -Complete and return the Field Correction Effectiveness Ch |
| Quantity | 13435 |
| Distribution | Worldwide-domestic nationwide and foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.