Recall Z-1535-2020— Beckman Coulter, Inc.

Name: FDA recall Z-1535-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-17

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2020-02-17, terminated 2021-05-13. It names one FDA 510(k) clearance: K101852. Product: iChemVELOCITY Strips, Catalog 800-7212. Reason: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-17
Terminated: 2021-05-13
Firm location: Miami, FL, 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

iChemVELOCITY Strips, Catalog 800-7212

Reason for recall

The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

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