Class 2 Device Recall QIAreach SARSCoV2 Antigen Test (60)

• Date Initiated by Firm: January 15, 2021
• Create Date: February 01, 2021
• Recall Status: Terminated on July 11, 2022
• Recall Number: Z-0941-2021
• Recall Event ID: 87205
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: SARS-CoV-2 Antigen Test
• Code Information: GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
• FEI Number: 3003572099
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: Donna Sowers; 240-686-7500
• Manufacturer Reason for Recall: QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
• FDA Determined Cause: Under Investigation by 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.