Known Identifiers & Locations
FEI Numbers
3005248192
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (5)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0004-2022 |
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason: There is a potential for false positive results.
|
2021-09-02 |
Terminated
|
View Details
|
| Z-0005-2022 |
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Reason: There is a potential for false positive results.
|
2021-09-02 |
Terminated
|
View Details
|
| Z-0006-2022 |
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason: There is a potential for false positive results.
|
2021-09-02 |
Terminated
|
View Details
|
| Z-0007-2022 |
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason: There is a potential for false positive results.
|
2021-09-02 |
Terminated
|
View Details
|
| Z-0008-2022 |
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.
|
2021-09-02 |
Terminated
|
View Details
|
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AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.