Z-0462-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 742 devices
Product Description
Alinity m System, Part No. 08N53-002
Reason for Recall
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Distribution Pattern
Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam
Code Information
Alinity m System, Model 08N53-002, all serial numbers