Recall Z-0269-2023— Beckman Coulter, Inc.

Name: FDA recall Z-0269-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-03

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2022-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280. Reason: Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-03
Firm location: West Sacramento, CA, United States

Product description

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Reason for recall

Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

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