SARS-CoV-2 Antigen Test
Reported: February 10, 2021 Initiated: January 15, 2021 #Z-0941-2021
Product Description
SARS-CoV-2 Antigen Test
Reason for Recall
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Details
- Recalling Firm
- Qiagen Sciences LLC
- Units Affected
- 1092 boxes of 60 (65,520 e-sticks)
- Distribution
- Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
- Location
- Germantown, MD
Frequently Asked Questions
What product was recalled? ▼
SARS-CoV-2 Antigen Test. Recalled by Qiagen Sciences LLC. Units affected: 1092 boxes of 60 (65,520 e-sticks).
Why was this product recalled? ▼
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0941-2021.
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