Recall Z-0006-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
| Date | Oct 14, 2021 (initiated Sep 2, 2021) |
| Status | Terminated |
| Reason | There is a potential for false positive results. |
| Root cause | Device Design |
| Action | The firm issued an Urgent Field Safety Notice/Field Correction Recall 09/02/2021 to all impacted customers. Per the customer letter, all positives are to be considered presumptive until the Alinity m SARS-CoV-2 Application Specification file version 5 or the updated Alinity m Resp-4-Plex Application Specification file is implemented at the customer site. On 03/30/2022, Abbott Molecular issued a follow-up Urgent Field Safety Notice/Field Correction Recall letter to all customers who ordered Alinity m SARS-CoV-2 AMP Kit Emergency Use Authorization (EUA), List Number 09N78-095 and/or Alinity m |
| Quantity | 71314 units |
| Distribution | Worldwide Distribution. US Nationwide, 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, SLOVE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.