Z-0499-2019Class II

Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the...

Name: Z-0499-2019 Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-10-11 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in... on 2018-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0499-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-11
Posted: 2018-11-27
Terminated: 2020-06-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Reason for recall: 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. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.
Root cause tag: manufacturing process
FDA 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 Check Form attached to the letter within 30 days. -If you have received any complaints of illness or adverse events associated with the product listed in Table 1 of the letter, immediately contact your local Siemens Customer Care Center or their local Siemens Technical Support Representative
Quantity in commerce: 13435
Distribution: Worldwide-domestic nationwide and foreign distribution.
Product codes and lots: 18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0499-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0499-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-27

Product code CFJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)