Qiagen GmbH - QIAGEN QIAstatDx - Class 2 Recall
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts

INFLUENZINUM (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 ivr-228 (h3n2) hemagglutinin antigen (uv, formaldehyde inactivated), influenza b virus b/michigan/01/2021 hemagglutinin antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated)) pellet [Boiron]
Updated Date: Fri, 21 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 21, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen, influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen, influenza b virus b/austria/1359417/2021 recombinant hemagglutinin antigen, and influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen) injection FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/west virginia/30/2022 (h1n1) recombinant hemagglutinin antigen, influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen, influenza b virus b/austria/1359417/2021 recombinant hemagglutinin antigen, and influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen) injection [Sanofi Pasteur Inc.]
Updated Date: Fri, 14 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 14, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/guangdong-maonan/swl1536/2019 cnic-1909 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated)) injection, suspension FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated)) injection, suspension FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Fri, 14 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 14, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension FLUZONE QUADRIVALENT .......ivated)) injection, suspension FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Thu, 13 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 13, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUCELVAX QUADRIVALENT (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated)) injection, suspension FLUCELVAX QUADRIVALENT (influenza a virus a/georgia/12/2022 crv-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated),influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, ropiolactone inactivated),influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated)) injection, suspension [Seqirus Inc.]
Updated Date: Tue, 11 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 11, 2023 Category: Drugs & Pharmacology Source Type: alerts

AFLURIA QUADRIVALENT (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (propiolactone inactivated), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (propiolactone inactivated), influenza b virus b/austria/1359417/2021 bvr-26 antigen (propiolactone inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (propiolactone inactivated)) injection, suspension [Seqirus PTY LTD.]
Updated Date: Mon, 10 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 10, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUAD QUADRIVALENT (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/austria/1359417/2021 bvr-26 antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (formaldehyde inactivated)) injection, suspension [Seqirus, Inc.]
Updated Date: Fri, 07 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 7, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/guangdong-maonan/swl1536/2019 cnic-1909 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated)) injection, suspension FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Mon, 01 May 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - May 1, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE (influenza a virus a/sydney/5/2021 san-013 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated), and influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Fri, 28 Apr 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 28, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE HIGH-DOSE (influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/maryland/15/2016 bx-69a (a b/colorado/6/2017-like virus) antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Fri, 28 Apr 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 28, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension FLUZONE QUADRIVALENT .......ted)) injection, suspension FLUZONE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/tasmania/503/2020 ivr-221 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Tue, 04 Apr 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 4, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUCELVAX QUADRIVALENT (influenza a virus a/delaware/55/2019 cvr-45 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated)) injection, suspension [Seqirus Inc.]
Updated Date: Wed, 08 Mar 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 8, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUAD QUADRIVALENT (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/austria/1359417/2021 bvr-26 antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 bvr-1b antigen (formaldehyde inactivated)) injection, suspension [Seqirus, Inc.]
Updated Date: Wed, 08 Mar 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 8, 2023 Category: Drugs & Pharmacology Source Type: alerts

FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection, suspension [Sanofi Pasteur Inc.]
Updated Date: Mon, 06 Mar 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 6, 2023 Category: Drugs & Pharmacology Source Type: alerts