Dimension Vista HbA1c
FDA Recall Z-0127-2015 · Posted 2014-10-24
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLCP
Date Initiated2014-08-14
Date Terminated2015-08-10
Product Quantity20043
Reason for Recall
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
Firm Action
An Urgent Medical Device Correction, dated August 2014, was provided to all Dimension Vista HbA1c customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.