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Terminated

SARS-CoV-2 Antigen Test

FDA Recall Z-0941-2021 · Posted None

Recalling FirmQiagen Sciences LLC
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-01-15
Date Terminated2022-07-11
Product Quantity1092 boxes of 60 (65,520 e-sticks)

Reason for Recall

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

Firm Action

On 01/13/2021, Qiagen issued Urgent Medical Device Correction notices to customers via phone and email. Customers were advised to do the following stop using the product and return any remaining product back to Qiagen.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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