Terminated

iChem VELOCITY Urine Chemistry Analyzer

FDA Recall Z-0843-2020 · Posted None

Recalling FirmBeckman Coulter Inc.

Recall StatusTerminated

Product CodeKQO

Date Initiated2019-11-07

Date Terminated2023-09-11

Product Quantity4314 units

Reason for Recall

Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.

Firm Action

The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letters on 11/07/2019. The letter explained the problem and how to recognize if the S3 flag has been disabled in the instrument. The letter further instructs the following: - Review results to determine if samples report an SG result of >1.060 or an SG result of S3 - If the SG result is >1.060 or S3, test samples for SG using an alternate method* determined by your laboratory - If persistent SG results are >1.060 or persistent S3 results are seen, contact your local Beckman Coulter Representative If you have any questions regarding this notice, please contact Beckman Coulter Customer Support Center: Via our website: http://www.beckmancoulter.com Support > Request Instrument Support. By phone: call 800-526-7694 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Macau, Malaysia, Maldives, Mexico, Moldova, Montenegro, Morocco, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.

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.