Recall Z-2144-2023— Beckman Coulter Biomedical GmbH

Name: FDA recall Z-2144-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-02

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Biomedical GmbH, initiated 2023-06-02. It names one FDA 510(k) clearance: K190298. Product: Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly. Reason: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results.

Recalling firm: Beckman Coulter Biomedical GmbH
Classification: Class II
Status: Ongoing
Initiated: 2023-06-02
Firm location: Munchen, 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

Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Reason for recall

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

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