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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 May 19, 2023
Date Posted July 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-2246-2023
Recall Event ID 92609
Product Classification COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
Product QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.)
Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection
REF: 691214
Code Information LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17
Recalling Firm/
Manufacturer		 Qiagen GmbH
Qiagen Str. 1
Hilden Germany
Manufacturer Reason
for Recall		 Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
FDA Determined
Cause 2		 Process control
Action Qiagen issued a customer letter (Urgent Medical Device Correction (REF 691223) or Urgent Field Safety notice (REF 691214) via e-mail on 5/19/23. Letter states reason for recall, health risk and action to take: Do not use the remaining stock of cartridges of LOTs 175010704 and 175011354. 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. " Review this notice with your laboratory/medical director. " 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 02 June 2023. 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 4155 kits
Distribution DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA
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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