Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Reason: There is a potential for false positive results.

Code information: List Number: 09N79-096, UDI 00884999049390 Lot/Serial, Expiration: 513424, 10/13/2021; 513771, 10/13/2021; 513861, 11/06/2021; 514503, 11/19/2021; 515652, 12/02/2021; 516411, 11/06/2021; 517877, 12/02/2021; 518436, 12/10/2021; 518877, 12/10/2021; 519091, 11/06/2021; 519243, 05/10/2022; 519582, 05/10/2022; 519969, 05/10/2022; 520356, 05/10/2022; 520695, 07/08/2022; 522088, 08/04/2022; 522128, 08/26/2022; 523152, 10/10/2022; 524433, 01/15/2023; 526710, 01/21/2023; 527845, 02/08/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.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.