PlainRecalls
FDA Devices Moderate Class II Terminated

iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used fo

Reported: March 8, 2017 Initiated: January 30, 2017 #Z-1384-2017

Product Description

iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips

Reason for Recall

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

Details

Recalling Firm
Beckman Coulter Inc.
Units 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, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela.
Location
Brea, CA

Frequently Asked Questions

What product was recalled?
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips. Recalled by Beckman Coulter Inc.. Units affected: 3175 units total (1697 units in US).
Why was this product recalled?
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1384-2017.