fda
5 records
FDA Device Recall: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample coll
2023-06-21
Class II — Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical int...
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FDA Device Recall: LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160801
2022-11-02
Class III — Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs...
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FDA Device Recall: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
2022-07-27
Class II — Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
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FDA Device Recall: LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
2022-07-27
Class II — Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
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FDA Device Recall: LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe A
2021-02-24
Class II — Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary trea...
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ny_corps
1 records
NY Corp: LUMIRADX, INC.
2020-07-13
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Delaware
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