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Terminated

iChemVELOCITY Strips, Catalog 800-7212

FDA Recall Z-1535-2020 · Posted None

Recalling FirmBeckman Coulter, Inc.
Recall StatusTerminated
Product CodeKQO
Date Initiated2020-02-17
Date Terminated2021-05-13
Product Quantity10822 vials

Reason for Recall

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

Firm Action

An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution in US including Puerto Rico, Canada, and Taiwan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris I · 2011-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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