Recall Z-2747-2020 ยท LCP Assay, Glycosylated Hemoglobin
Siemens Healthcare Diagnostics, Inc.
DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
| Date | Jun 30, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | Siemens Healthcare Diagnostics issues a field safety notice date June 2020 to customers |
| Quantity | 1800 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071466 | DCA VANTAGE, MODEL 5075 Siemens Medical Solutions Diagnostics, Oct 9, 2007 |