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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge

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 Class 2 Device Recall Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridgesee related information
Date Initiated by FirmOctober 11, 2018
Create DateNovember 27, 2018
Recall Status1 Terminated 3 on June 29, 2020
Recall NumberZ-0499-2019
Recall Event ID 81433
Product Classification Nad reduction/nadh oxidation, lactate dehydrogenase - Product Code CFJ
ProductDimension 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
Code Information 18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA 
FEI Number 2517506
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionAn 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 Commerce13435
DistributionWorldwide-domestic nationwide and foreign distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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