Abbott Molecular, Inc. Recall 89167
Description: Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc. Recall 89167 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0461-2022 |
| Event ID | 89167 |
| Event Description | Alinity m System, Part No. 08N53-002 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 742 devices |
| Recall Reason | There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. |
| Device Classification | 20220112 |
| Device Code Info | Alinity m System, Model 08N53-002, all serial numbers |
| Center Classification Date | 20220106 |
| Recall Initiation Date | 20211206 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | |
| Similar To |