Abbott Molecular, Inc. Recall 88626
Description: Alinity m SARS-CoV-2 Amp Kit (Non-US Assay)
Abbott Molecular, Inc. Recall 88626 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0007-2022 |
| Event ID | 88626 |
| Event Description | Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) |
| Product Type | Devices |
| Distribution | Distribution throughout the United States Nationwide. OUS Distribution: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA COLOMBIA CZECH REPUBLIC ESTONIA FINLAND FRANCE GERMANY HONG KONG IRELAND ISRAEL ITALY JAPAN MALAYSIA MONTENEGRO NETHERLANDS NEW ZEALAND NORWAY POLAND PORTUGAL ROMANIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND UNITED KINGDOM VIETNAM |
| Quantity | 563 unitsin total |
| Recall Reason | There is a potential for false positive results. |
| Device Classification | 20211020 |
| Device Code Info | List Number: 09N78-091; Lot/Serial and Expiration: 520596 06/18/2022 |
| Center Classification Date | 20211014 |
| Recall Initiation Date | 20210902 |
| Recalling Firm | Abbott Molecular, Inc. |
| Initial Notification | Letter |
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