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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 Modelsee related information
Date Initiated by FirmJune 30, 2020
Create DateJuly 31, 2020
Recall Status1 Terminated 3 on November 17, 2020
Recall NumberZ-2747-2020
Recall Event ID 85980
510(K)NumberK071466 
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
ProductDCA 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 ContactCustomer 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
ActionSiemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Quantity in Commerce1800 units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LCP
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