Recall Z-0127-2015
Siemens Healthcare Diagnostics, Inc. · initiated August 14, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista HbA1c
Codes / lots: catalog #K3105A, material #10470481, All in-date lots
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
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0127-2015
- Initiated
- August 14, 2014
- Posted by FDA
- October 24, 2014
- Terminated
- August 10, 2015
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 20043
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE