Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Check against the official notice below — it lists the full affected range.
Abbott Molecular, Inc. is recalling 8,469 units of the Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File because there is a potential for false positive results. The affected product was distributed worldwide, including in the United States and numerous other countries. The recall involves multiple lot numbers with expiration dates ranging from September 2021 through January 2023.
The source document does not specify a remedy or recommended action for consumers who may have been affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for false positive results.
Reason for recall: There is a potential for false positive results. 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, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VI Quantity: 8469 units Lot/code info: List Number: 09N79-096, UDI 00884999049390; Lot/Serial, Expiration: 514074, 09/15/2021; 519243, 05/10/2022; 519243, 5/10/2022; 522088, 8/4/2022; 522128, 8/26/2022; 523152, 10/10/2022; 524433, 1/15/2023; 526710, 1/21/2023; 527845, 2/8/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.