Recall Z-2730-2017— Beckman Coulter Inc

Name: FDA recall Z-2730-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-15

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc, initiated 2017-05-15, terminated 2020-09-09. It names one FDA 510(k) clearance: K071277. Product: Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.. Reason: The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1..

Recalling firm: Beckman Coulter Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Terminated: 2020-09-09
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071277 — SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMSBeckman Coulter, Inc.·cleared 2007-06-01

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 Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

Reason for recall

The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.

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