DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples,

FDA device recall Z-2691-2024 · posted 2024-08-21 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Mishima K.K.

Reason for recall

Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.

Action taken

during the week of 07/25/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter via email and postal mail to customers informing them that after the analyzer processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and an error code "9000" will be reported. Customer are instructed: . Monitor the rerun/reflex process if a rerun/reflex rack is held in the buffer area, manually retrieve the rack from the buffer area, manually order the rerun/reflex test and reload the sample onto the sample handler. Refer to Rerunning a Test section of the Instructions for Use on page 10-34. Beckman Coulter has implemented the correction with software V1.4 which was released on 06/21/2024. A Beckman Coulter service representative will contact customers to schedule the software upgrade. For any questions or assistance - contact the Beckman Coulter Customer Support via email https://www.beckmancoulter.com/en/support/contact-us

Root cause

Software design

Status

Open, Classified

Product code

JJE

Quantity affected

24 analyzers

Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, South Africa.

Date initiated

2024-07-10

Date posted

2024-08-21

Location

Nagaizumi-Cho Sunto-Gun, Japan

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