International safety notice
Urgent Field Safety Notice for Alinity m SARS-CoV-2 Amplification Reagent Kit Kit, Alinity m Resp-4-Plex Amplification Reagent Kit, Alinity m SARS-CoV-2 Amplification Reagent Kit Emergency Use Authorization (EUA) and Alinity m Resp-4-Plex Amplification Reagent by Abbott Molecular, Inc
Germany / BfArM · DEU · Jun 9, 2022
Key facts
| Title | Urgent Field Safety Notice for Alinity m SARS-CoV-2 Amplification Reagent Kit Kit, Alinity m Resp-4-Plex Amplification Reagent Kit, Alinity m SARS-CoV-2 Amplification Reagent Kit Emergency Use Authorization (EUA) and Alinity m Resp-4-Plex Amplification Reagent by Abbott Molecular, Inc |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Alinity m SARS-CoV-2 Amplification Reagent Kit Kit, Alinity m Resp-4-Plex Amplification Reagent Kit, Alinity m SARS-CoV-2 Amplification Reagent Kit Emergency Use Authorization (EUA) and Alinity m Resp-4-Plex Amplification Reagent |
| Manufacturer | Abbott Molecular, Inc |
| Models | RESP-4-PIEX, 09N78-01E, 0.0078, 09N78-090, 09N79-01D, FA-AM-SEP2021-260, SARS-COV-2, 60018, 00884999049338, 0.0016, 09N79-090, 00884999049963 and 5 more |
| Date | Jun 9, 2022 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1