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Terminated

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.

FDA Recall Z-1937-2019 · Posted None

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeKQO
Date Initiated2018-10-18
Date Terminated2020-11-10
Product Quantity956,798/100 test strip vials

Reason for Recall

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

Firm Action

The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.

Root Cause

Component change control

Distribution Pattern

Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, 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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