Recall Z-0786-2024— Beckman Coulter, Inc.

Name: FDA recall Z-0786-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-19

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2023-12-19. It names one FDA 510(k) clearance: K022774. Product: REV 2 Flowcell Capsule Spare, Part Number: C04154. Reason: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-19
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K022774 — IQ 200 SYSTEMIntl. Remote Imaging Systems·cleared 2002-10-21

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

REV 2 Flowcell Capsule Spare, Part Number: C04154

Reason for recall

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

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