Recall Z-2488-2023— Beckman Coulter Inc.

Name: FDA recall Z-2488-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-12

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2023-07-12. It names one FDA 510(k) clearance: K073489. Product: Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2. Reason: Lipemic interference failed to meet the performance specification listed within the IFU..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-12
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K073489 — OLYMPUS IGA REAGENTOlympus America, Inc.·cleared 2008-02-11

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

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

Reason for recall

Lipemic interference failed to meet the performance specification listed within the IFU.

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