Qiagen Sciences LLC: Medical Device Recall in 2021 - (Recall #: Z-0941-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SARS-CoV-2 Antigen Test

Product Classification:

Class II

Date Initiated: January 15, 2021

Date Posted: February 10, 2021

Recall Number: Z-0941-2021

Event ID: 87205

Reason for Recall:

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

Status: Terminated

Product Quantity: 1092 boxes of 60 (65,520 e-sticks)

Code Information:

GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated