QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

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