Z-0004-2022 Class I Terminated
FDA device recall Z-0004-2022 was initiated by Abbott Molecular, Inc. on Sep 2, 2021 and is designated Class I. Reason for recall: There is a potential for false positive results. The recall status is terminated (terminated Jul 23, 2024). Affected quantity: 60563 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 20, 2021
- Initiation Date
- Sep 2, 2021
- Termination Date
- Jul 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60563 units
Product Description
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason for Recall
There is a potential for false positive results.
Distribution Pattern
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, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.
Code Information
List Number: 09N78-095, UDI 00884999049222; Lot/Serial, Expiration: 511810, 09/18/2021; 512026, 09/21/2021; 512900, 10/14/2021; 513146, 10/14/2021; 513583, 11/18/2021; 513959, 11/23/2021; 514176, 11/23/2021; 514216, 12/01/2021; 514819, 12/17/2021; 515052, 01/05/2022; 515653, 01/28/2022; 515949, 02/05/2022; 516085, 02/11/2022; 516611, 02/22/2022; 517139, 03/01/2022; 517355, 03/08/2022; 517999, 03/19/2022; 518266, 03/22/2022; 518435, 03/22/2022; 522689, 09/14/2022; 518670, 04/01/2022; 522691, 09/14/2022; 519124, 05/03/2022; 523309, 09/13/2022; 519583, 05/11/2022; 523468, 09/23/2022; 519785, 05/18/2022; 523621, 10/01/2022; 519968, 05/25/2022; 523946, 10/08/2022; 520216, 06/08/2022; 524203, 10/21/2022; 520699, 06/30/2022; 524438, 10/25/2022; 521106, 07/13/2022; 525862, 12/16/2022; 521654, 07/23/2022; 526394, 12/30/2022; 521842, 07/27/2022; 526484, 01/14/2023; 521857, 07/27/2022; 527399, 01/28/2023; 527400, 01/28/2023; 527540, 02/04/2023; 528026, 02/18/2023; List File 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0004-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026