FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0499-2019
- 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
- Status
- Terminated
- Initiated
- 2018-10-11
- Posted
- not on file
- Terminated
- 2020-06-29
- 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. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.
- 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
- 13435
- Distribution
- Worldwide-domestic nationwide and foreign distribution.
- Lot, serial or model codes
- 18240BA 18199BA 18162AC 18155BB 18106BC 18073BE 18036BC 17342BA
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CFJ
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28