FDA Recall
Terminated
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Recall: Z-2747-2020
·
Initiated June 30, 2020
Recall
- Recall Number
- Z-2747-2020
- Event Number
- 85980
- Firm
- Siemens Healthcare Diagnostics, Inc.
- FEI Number
- 2517506
- Product Code
- LCP
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- June 30, 2020
- Terminated
- November 17, 2020
- Address
- 500 Gbc Dr, Newark, DE, 19702-2466
Description
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Reason
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.
Action
Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Distribution
Nationwide
Quantity
1800 units