Class 2 Device Recall QIAstatDx Respiratory SARSCoV2

• Date Initiated by Firm: November 08, 2021
• Create Date: January 05, 2022
• Recall Status: Terminated on March 29, 2023
• Recall Number: Z-0455-2022
• Recall Event ID: 89130
• Product Classification: COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
• Product: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
• Code Information: LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567
• Recalling Firm/ Manufacturer: Qiagen Sciences LLC; 19300 Germantown Rd; Germantown MD 20874-1415
• For Additional Information Contact: Qiagen Technical Service Department; 800-362-7737
• Manufacturer Reason for Recall: The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
• FDA Determined Cause: Employee error
• Action: On November 8, 2021, the firm began notifying customers. Customers received an Urgent Medical Device Correction Notice via email. Customers were instructed to do the following: - Please check the cartridge SNs received from LOT 210209 against the list of affected cartridges shown in Table 1 (page 1). If you have received one of the affected cartridges, please contact QIAGEN Technical Service for a free-of-charge replacement. - If you have received one of the 16 affected cartridges and have not used it, please dispose of it immediately in accordance with your national and local safety and environmental regulations. - If you already used one of the affected cartridges from this LOT, please identify the results obtained with the affected SNs listed on Table 1 (page 1). For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned on page 1 to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed on clinical and/or epidemiological suspicion of the respective targets. - If you have remaining stocks from LOT 210209, cat. no 691223 with cartridge SNs not found in the list, you may still use these cartridges, as this issue is limited to the 16 cartridges listed on Table 1 (page 1). - Review this notice with your laboratory/medical director. - IMPORTANT: Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. - Complete the Acknowledgement of Receipt attached to the letter by November 22, 2021. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
• Quantity in Commerce: 376 kits
• Distribution: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.
• 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.