Recall Z-1386-2025— Beckman Coulter, Inc.

Name: FDA recall Z-1386-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-05

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-02-05. It names one FDA 510(k) clearance: K121214. Product: Access 2 Immunoassay Analyzer, Catalog Number 81600N. Reason: Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-05
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEMBeckman Coulter, Inc.·cleared 2013-06-14

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

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Reason for recall

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

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