Abbott Molecular, Inc. Recall 89757
Description: Alinity m HBV Application Specification File (US and CE)
Abbott Molecular, Inc. Recall 89757 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0883-2022 |
| Event ID | 89757 |
| Event Description | Alinity m HBV Application Specification File (US and CE) |
| Product Type | Devices |
| Distribution | US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam |
| Recall Reason | There is a potential for misquantitation high results of negative samples. |
| Device Classification | 20220413 |
| Device Code Info | List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00 |
| Center Classification Date | 20220406 |
| Recall Initiation Date | 20220304 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | Letter |
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