Atellica CI Analyzer. Catalog Numbers: 10947347.
- Recall Initiated
- November 4, 2024
- Posted
- December 4, 2024
- Recall Number
- Z-0597-2025
- Quantity
- 559 units
- Firm Location
- Tarrytown, NY
Reason for Recall
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.
Lot / Code Info
UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
Root Cause
Software design