—#168693

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

FDA product code: CFJ — Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: 18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide-domestic nationwide and foreign distribution.

Timeline

Recall initiated: 2018-10-11
Terminated: 2020-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.