Z-2441-2015 Class II Terminated
FDA device recall Z-2441-2015 was initiated by Iris Diagnostics on July 15, 2015 and is designated Class II. 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 … The recall status is terminated (terminated May 26, 2016). Affected quantity: 2,448 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- July 15, 2015
- Termination Date
- May 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,448 units
Product Description
Reason for Recall
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.