Recall Z-0127-2015 · LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
Dimension Vista HbA1c
| Date | Oct 24, 2014 (initiated Aug 14, 2014) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| 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. |
| Quantity | 20043 |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102045 | DIMENSION VISA HBA1C, MODEL K3105A Siemens Heatlhcare Diagnostics, Inc., Feb 14, 2011 |