Dimension Vista HbA1c
FDA device recall Z-0127-2015 · posted 2014-10-24 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 20043
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Date initiated
- 2014-08-14
- Date posted
- 2014-10-24
- Date terminated
- 2015-08-10
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISA HBA1C, MODEL K3105A (K102045) | Siemens Heatlhcare Diagnostics, Inc. | 2011-02-14 |