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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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