Z-2747-2020Class II

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

Name: Z-2747-2020 DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-06-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-06-30 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US on 2020-06-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2747-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-30
Posted: 2020-07-31
Terminated: 2020-11-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Product code: LCP Assay, Glycosylated Hemoglobin
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Quantity in commerce: 1800 units
Distribution: Nationwide
Product codes and lots: DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2747-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2747-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-07-31

Product code LCP

K071466Class IIDca Vantage, Model 5075Siemens Medical Solutions Diagnostics / cleared 2007-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)