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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista HbA1c

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  Class 2 Device Recall Dimension Vista HbA1c see related information
Date Initiated by Firm August 14, 2014
Date Posted October 24, 2014
Recall Status1 Terminated 3 on August 10, 2015
Recall Number Z-0127-2015
Recall Event ID 69334
510(K)Number K102045  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product Dimension Vista¿ HbA1c
Code Information catalog #K3105A, material #10470481, All in-date lots
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer 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 2		 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 in Commerce 20043
Distribution Worldwide Distribution: US (nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = SIEMENS HEATLHCARE DIAGNOSTICS INC
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