Iris Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-2441-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.

Product Classification:

Class II

Date Initiated: July 15, 2015

Date Posted: September 2, 2015

Recall Number: Z-2441-2015

Event ID: 71780

Reason for Recall:

Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.

Status: Terminated

Product Quantity: 2,448 units

Code Information:

All Serial Numbers

Distribution Pattern:

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated