Recalls / —
—#182370
Product
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
- FDA product code
- LCP — Assay, Glycosylated Hemoglobin
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K071466
- Affected lot / code info
- DCA Vantage Handheld Barcode Scanner #11306432 Model: DS4308 - HC0015BZZWW
Why it was recalled
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 (FDA determination)
Labeling design
Action the firm took
Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 500 Gbc Dr, Newark, Delaware 19702-2466
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-06-30
- Terminated
- 2020-11-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #182370. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.