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Terminated

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

FDA Recall Z-2747-2020 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLCP
Date Initiated2020-06-30
Date Terminated2020-11-17
Product Quantity1800 units

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.

Firm Action

Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers

Root Cause

Labeling design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071466DCA VANTAGE, MODEL 5075Siemens Medical Solutions Diagnostics · 2007-10-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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