Recall Z-1937-2019— Beckman Coulter Inc.

Name: FDA recall Z-1937-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-18

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-10-18, terminated 2020-11-10. It names one FDA 510(k) clearance: K101852. Product: iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.. Reason: Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-18
Terminated: 2020-11-10
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 Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

Reason for recall

Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

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