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U.S. Department of Health and Human Services

Class 1 Device Recall FilterTips (1500 ul) used with QIAsymphony SP/AS Instruments

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 Class 1 Device Recall FilterTips (1500 ul) used with QIAsymphony SP/AS Instrumentssee related information
Date Initiated by FirmJune 05, 2019
Date PostedAugust 01, 2019
Recall Status1 Terminated 3 on August 28, 2020
Recall NumberZ-2088-2019
Recall Event ID 83199
Product Classification Clinical sample concentrator - Product Code JJH
ProductFilter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
Code Information Lot Numbers: 0605020019 and 0605020020
FEI Number 3003572099
Recalling Firm/
Manufacturer		 Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information ContactSAME
240-686-7500
Manufacturer Reason
for Recall		Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
FDA Determined
Cause 2		Process control
ActionQIAGEN issued Urgent Device Notification dated June 5, 2019 stating problem, health risk and action to take: Forward this information to all individuals and departments who are using the above listed kit within your organization. If you are not the end user, please forward this notice to the product end user. If you have any remaining stocks of Filter-Tips, 1500 l (1024) REF 997024, lots 0605020019 and 0605020020, DO NOT USE them. For a free-of-charge replacement, please contact QIAGEN Technical Service. Dispose of the product in accordance with your national and local safety and environmental regulations. l Review this notice with your laboratory/medical director. l If you have used the affected kits with lots 0605020019 and/or 0605020020, we recommend a review of the corresponding results. l Complete the Acknowledgement of Receipt form attached to this letter by June 12, 2019 and email it to quality.communications@qiagen.com. Questions or concerns, contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
Quantity in Commerce1240 Kits
DistributionUS Nationwide distribution
Total Product Life CycleTPLC 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.
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