| 2026-04-06 |
Class II
|
Ongoing |
Z-2169-2026 |
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. |
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Product has the potential for false positive results |
| 2025-06-17 |
Class II
|
Ongoing |
Z-2545-2025 |
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC |
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Dipstick strep A test has potential for false positive results. |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1637-2024 |
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests |
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There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instance… |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1636-2024 |
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests |
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There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instance… |
| 2024-01-03 |
Class II
|
Ongoing |
Z-1086-2024 |
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 … |
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One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expi… |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1308-2023 |
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Cat… |
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Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert… |
| 2021-08-13 |
Class II
|
Terminated |
Z-2477-2021 |
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time… |
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Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplificati… |
| 2021-04-27 |
Class I
|
Terminated |
Z-1928-2021 |
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent |
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In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplif… |
| 2020-09-25 |
Class II
|
Terminated |
Z-0428-2021 |
QUIDEL Sofia SARS Antigen FIA IVD REF 20374 |
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Due to false positive results. |
| 2020-09-17 |
Class II
|
Terminated |
Z-0124-2021 |
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay … |
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Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well … |