Z-0460-2022 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 potential for abnormal (non-sigmoidal) amplification curves.
Distribution Pattern
Worldwide distribution - US Nationwide 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
Model 08N53-002, all serial numbers