—#130239

Product

Dimension Vista HbA1c

FDA product code: LCP — Assay, Glycosylated Hemoglobin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K102045
Affected lot / code info: catalog #K3105A, material #10470481, All in-date lots

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Canada.

Timeline

Recall initiated: 2014-08-14
Posted by FDA: 2014-10-24
Terminated: 2015-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.