Recall Z-0958-2013— Beckman Coulter Inc.

Name: FDA recall Z-0958-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-28

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-12-28, terminated 2013-10-17. It names 2 FDA 510(k) clearances: K934361, K924692. Product: Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.. Reason: Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-28
Terminated: 2013-10-17
Firm location: Brea, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K934361 — OLYMPUS CREATININE REAGENTOlympus Corp.·cleared 1993-11-16
K924692 — OLYMPUS CREATININE REAGENTOlympus Corp.·cleared 1992-10-19

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

Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.

Reason for recall

Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.

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