Abbott Molecular, Inc. Recall 89166
Description: Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc. Recall 89166 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0460-2022 |
| Event ID | 89166 |
| 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 potential for abnormal (non-sigmoidal) amplification curves. |
| Device Classification | 20220112 |
| Device Code Info | Model 08N53-002, all serial numbers |
| Center Classification Date | 20220106 |
| Recall Initiation Date | 20211206 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | |
| Similar To |