QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Reported: November 18, 2020 Initiated: September 25, 2020 #Z-0428-2021
Product Description
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Reason for Recall
Due to false positive results.
Details
- Recalling Firm
- Quidel Corporation
- Units Affected
- 8,628 kits
- Distribution
- U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
QUIDEL Sofia SARS Antigen FIA IVD REF 20374. Recalled by Quidel Corporation. Units affected: 8,628 kits.
Why was this product recalled? ▼
Due to false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0428-2021.
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