Device product

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

Z-0007-2022

September 02, 2021

Class I

Product summary

Firm: Abbott Molecular, Inc.
Event: Event 88626
Status: Terminated
Classification: Class I
Quantity: 11408 units
Official record key: device-enforcement:Z-0007-2022

Official wording

Reason: There is a potential for false positive results.

Code information: List Number: 09N78-091, UDI 00884999049222; Lot/Serial, Expiration: 520596, 06/18/2022; 520952, 07/09/2022; 524054, 10/18/2022; 524965, 10/25/2022; 525462, 12/10/2022; 525768, 12/16/2022; 526708, 01/18/2023; 527842, 02/08/2023; 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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is a potential for false positive results.