Quidel SARS Antigen Test Kits Recalled for False Positive Results
Quidel is recalling 8,628 SARS Antigen FIA test kits due to false positive results. The affected units were distributed to 24 U.S. states.
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. The hazard involves false positive results, which is a risk-of-harm scenario where injury has not been explicitly reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Quidel Corporation is recalling 8,628 units of the QUIDEL Sofia SARS Antigen FIA IVD (REF 20374). The recall was initiated because the test kits are associated with false positive results.
The affected products are identified by Model Number 20374, Lot Number 706142, and Cassette numbers 168365 through 166817. The UPC A GTIN-12 is 0 14613 33908 2. These kits were distributed in the United States to the following states: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected test kits and contact Quidel Corporation for further instructions or a replacement.
The recalled product
- Product
- QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Manufacturer
- Quidel Corporation
- Hazard
- Affected units
- 8,628
Distribution
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