Recall Z-1944-2020— Beckman Coulter Inc.

Name: FDA recall Z-1944-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-30

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2020-03-30, terminated 2023-08-31. It names one FDA 510(k) clearance: K101852. Product: iChem¿VELOCITY Urine Chemistry System-. Reason: A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-30
Terminated: 2023-08-31
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 System-

Reason for recall

A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

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