FDA-Device2020-08-12Class II

DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

Siemens Healthcare Diagnostics, Inc.
Hazard

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.

Sold states
Nationwide
Affected count
1800 units
Manufactured in
500 Gbc Dr, Newark, DE, United States
Products
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2747-2020

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