Recall Z-0889-2026— Beckman Coulter, Inc.

Name: FDA recall Z-0889-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-07

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-11-07. It names one FDA 510(k) clearance: K121214. Product: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901. Reason: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-07
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 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

Reason for recall

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

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