Abbott Molecular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0006-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Product Classification:

Class I

Date Initiated: September 2, 2021

Date Posted: October 20, 2021

Recall Number: Z-0006-2022

Event ID: 88626

Reason for Recall:

There is a potential for false positive results.

Status: Terminated

Product Quantity: 71314 units

Code Information:

List Number: 09N78-090, UDI UDI 00884999049222; Lot/Serial, Expiration: 511468, 09/15/2021; 511504, 09/15/2021; 511505, 09/15/2021; 512025, 09/21/2021; 512416, 09/18/2021; 512417, 09/18/2021; 512705, 09/21/2021; 512712, 10/07/2021; 512898, 10/07/2021; 513147, 10/14/2021; 513629, 11/18/2021; 514359, 12/01/2021; 514762, 12/17/2021; 515053, 01/05/2022; 515415, 01/15/2022; 515416, 01/15/2022; 515948, 01/28/2022; 516084, 02/05/2022; 516430, 02/17/2022; 516431, 02/18/2022; 516612, 02/25/2022; 516636, 03/01/2022; 516910, 03/04/2022; 516911, 02/11/2022; 517009, 02/18/2022; 517138, 02/25/2022; 517354, 03/08/2022; 517876, 03/19/2022; 517998, 03/19/2022; 518668, 04/01/2022; 518669, 04/20/2022; 518878, 04/20/2022; 519022, 04/30/2022; 519122, 04/30/2022; 519372, 05/03/2022; 519373, 05/11/2022; 519784, 05/18/2022; 519967, 05/25/2022; 520221, 06/08/2022; 520387, 06/15/2022; 520388, 06/15/2022; 520563, 06/18/2022; 527137, 01/20/2023; 527205, 01/20/2023; 527402, 01/28/2023; 527497, 01/28/2023; 527576, 02/04/2023; 527642, 02/08/2023; 527844, 02/17/2023; 528024, 02/18/2023; List Number: 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo

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.

Voluntary or Mandated:

Voluntary: Firm initiated