Recall Z-2983-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Biomedical GmbH
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immun
| Date | Jun 17, 2020 |
| Status | Terminated |
| Reason | The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system . |
| Root cause | Device Design |
| Action | The Urgent Medical Device Recall letters were sent via first class mail on 06/19/20. The actions to be taken by consignees are as follows: Avoid Duplicate IDs; DO NOT Re-use Sample IDs As indicated in the DxA 5000 instructions for use, ensure that only unique sample barcode IDs are used. Be aware of the difference between duplicate sample IDs and the re-use of the same sample ID, as the instrument appropriately detects duplicates, but not re-used sample IDs. *Duplicate sample IDs are defined as samples with the same ID concurrently being run on the instrument. *Re-used sample IDs are defined a |
| Quantity | 32 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 Beckman Coulter Biomedical GmbH, Oct 4, 2019 |