Qiagen SARS-CoV-2 Antigen Test Recalled for Potential False Positive Results
Qiagen Sciences LLC is recalling SARS-CoV-2 Antigen Tests due to the potential for false positive results in some patient samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (false positive diagnostic results) where specific injury or illness reports are not detailed in the source text, fitting the High severity criteria.
Plain-English summary
Qiagen Sciences LLC is recalling specific lots of its SARS-CoV-2 Antigen Test. The recall involves 1,092 boxes containing 65,520 e-sticks. The affected lots are 86651, 86652, 86653, 86654, and 86659, identified by GTIN 04053228039785 and Catalog # 646533.
The recall was initiated because Qiagen became aware of the potential for false positive results to occur with some patient samples. This issue may lead to incorrect diagnostic conclusions for patients using the affected test kits.
The affected products were distributed domestically in Arizona, California, Colorado, District of Columbia, Florida, Hawaii, Illinois, Kentucky, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Rhode Island, Texas, Washington, and Wyoming. Users should check their inventory for the specific lot numbers listed above and stop using the affected products.
The recalled product
- Product
- SARS-CoV-2 Antigen Test
- Manufacturer
- Qiagen Sciences LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- GTIN: 04053228039785
- Catalog #: 646533
- Lot #: 86651
- 86652
- 86653
- 86654
- 86659.
Distribution
Related recalls
Same manufacturer · Qiagen Sciences LLC
See all →- HighRespiratory Diagnostic Cartridges Recalled for Risk of False Test Results
FDA (Devices) · 2025-04-09
- HighQiagen QIAcube Connect MDx heating failure may cause erroneous diagnostic results
FDA (Devices) · 2024-07-24
- HighNucleic Acid Isolation Device Recall: EZ2 Connect MDx-IVD Heater Failure
FDA (Devices) · 2024-04-17
- HighQIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk
FDA (Devices) · 2023-06-14
- HighLaboratory device displays incorrect sample volume guidance during setup
FDA (Devices) · 2022-09-21
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11