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U.S. Department of Health and Human Services

Class 2 Device Recall QIAstatDx Respiratory SARSCoV2 Panel

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  Class 2 Device Recall QIAstatDx Respiratory SARSCoV2 Panel see related information
Date Initiated by Firm April 28, 2023
Date Posted June 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-1683-2023
Recall Event ID 92298
Product Classification COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
Product QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Code Information GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.
Recalling Firm/
Manufacturer		 Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact
800-362-7737
Manufacturer Reason
for Recall		 Faulty cartridges in the lot could result in false test results.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Correction notification letter dated April 2023 was sent to customers. Actions to be taken by customer/user ¿ Please check if you have remaining stock of LOT 175011350. Please DO NOT use it. Dispose of it immediately in accordance to your national and local safety and environmental regulations. ¿ Please contact QIAGEN Technical Services for a free-of-charge replacement. ¿ If you already used cartridges from this LOT, please identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned in this notice 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. ¿ 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 Form attached to this letter by 14 May 2023. Actions taken by QIAGEN QIAGEN was able to identify the root cause of the issue and has implemented immediate actions to ensure that the currently produced cartridges will not cause this issue moving forward. If you have any questions or concerns, please contact your local QIAGEN Technical Services Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
Quantity in Commerce 347 kits
Distribution US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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