Recall Z-2983-2020— Beckman Coulter Biomedical GmbH

Name: FDA recall Z-2983-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-17

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Biomedical GmbH, initiated 2020-06-17, terminated 2022-08-24. It names one FDA 510(k) clearance: K190298. Product: 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 Immunoassay analyzer, into a unified workstation on a track system.. 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 ..

Recalling firm: Beckman Coulter Biomedical GmbH
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Terminated: 2022-08-24
Firm location: Munich, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH·cleared 2019-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 Immunoassay analyzer, into a unified workstation on a track system.

Reason for recall

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 .

Data sourced from openFDA. This site is unofficial and independent of the FDA.