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U.S. Department of Health and Human Services

Class 2 Device Recall DCA Vantage Handheld Barcode Scanner Zebra Model

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  Class 2 Device Recall DCA Vantage Handheld Barcode Scanner Zebra Model see related information
Date Initiated by Firm June 30, 2020
Create Date July 31, 2020
Recall Status1 Terminated 3 on November 17, 2020
Recall Number Z-2747-2020
Recall Event ID 85980
510(K)Number K071466  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 -
HC0015BZZWW external accessory to DCA Vantage Analyzer US
Code Information DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr
Newark DE 19702-2466
For Additional Information Contact Customer Solution Center
312-275-7795
Manufacturer Reason
for Recall		 If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.
FDA Determined
Cause 2		 Labeling design
Action Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Quantity in Commerce 1800 units
Distribution Nationwide
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 MEDICAL SOLUTIONS DIAGNOSTICS
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