Recall Z-2441-2015
Iris Diagnostics · initiated July 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: All Serial Numbers
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
An Urgent Medical Device Recall letter dated 7/15/15 was sent to all customers who purchased the iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips REF 800-7212 and 800-7212-001. As a result of internal investigations following customer complaints, Iris International has determined that the iChemVELOCITY systems do not maintain the on-board strip stability claim of 5 days at 18-28C at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns regarding the recall notice, are instructed to contact Beckman Coulter Customer Support at http://www.beckmancoulter.com or call (800) 526-7694 in US and Canada.
Details
- Recall number
- Z-2441-2015
- Initiated
- July 15, 2015
- Posted by FDA
- August 21, 2015
- Terminated
- May 26, 2016
- Product code
- KQO – Automated Urinalysis System
- Quantity
- 2,448 units
- Distribution
- 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…
- Recalling firm
- Iris Diagnostics, Chatsworth, CA