Recall Z-1609-2026— Beckman Coulter, Inc.

Name: FDA recall Z-1609-2026
Creator: U.S. Food and Drug Administration
Published: 2025-07-24

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-07-24. It names one FDA 510(k) clearance: K202343. Product: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.. Reason: Due to the likely presence of contamination in well(s)..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-24
Firm location: West Sacramento, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.·cleared 2020-11-16

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

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Reason for recall

Due to the likely presence of contamination in well(s).

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