Recall Z-1608-2023— Beckman Coulter Inc.

Name: FDA recall Z-1608-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-05

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2023-04-05. It names one FDA 510(k) clearance: K131546. Product: Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL. Reason: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-05
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131546 — AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.·cleared 2013-10-09

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 Bicarbonate, REF: OS6637, 4x173 mL

Reason for recall

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

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