Recall Z-0843-2020— Beckman Coulter Inc.

Name: FDA recall Z-0843-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-07

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2019-11-07, terminated 2023-09-11. It names one FDA 510(k) clearance: K101852. Product: iChem VELOCITY Urine Chemistry Analyzer. Reason: Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Terminated: 2023-09-11
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris I·cleared 2011-03-23

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

iChem VELOCITY Urine Chemistry Analyzer

Reason for recall

Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

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