Abbott Molecular, Inc. Recall 89168
Description: Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc. Recall 89168 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0462-2022 |
| Event ID | 89168 |
| Event Description | Alinity m System, Part No. 08N53-002 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 742 devices |
| Recall Reason | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. |
| 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 | |
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