Dimension Vista System-Lactate Dehydrogenase Flex (LDI) Assay (2018-10-17)

Starting date:

October 17, 2018

Posting date:

November 2, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68180

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  Reason
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  Affected products

Affected products

Dimension Vista System-Lactate Dehydrogenase Flex (LDI) Assay

Reason

Siemens Healthcare diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDH) 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 results.

Affected products