iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103,

FDA device recall Z-1384-2017 · posted 2017-03-01 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.

Action taken

Beckman Coulter/Iris sent an Urgent Medical Device Recall letter dated January 30, 2017 to all affected customers to inform them that Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. Customers were informed that Inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. Incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. The greatest impact could occur when proteinuria is not detected. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local support representative: Via our website, at http://www.beckmancoulter.com By phone, call 800 854-3633 in the United States and Canada

Root cause

Device Design

Status

Terminated

Product code

KQO

Quantity affected

3175 units total (1697 units in US)

Distribution

Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Cro

Date initiated

2017-01-30

Date posted

2017-03-01

Date terminated

2017-08-19

Location

Brea, CA

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