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U.S. Department of Health and Human Services

Class 2 Device Recall LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit

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 Class 2 Device Recall LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kitsee related information
Date Initiated by FirmNovember 24, 2008
Date PostedMarch 06, 2009
Recall Status1 Terminated 3 on August 10, 2012
Recall NumberZ-0953-2009
Recall Event ID 50511
510(K)NumberK974302 
Product Classification SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
ProductLIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet
Code Information Lot Numbers: JBC1531415, TR1480748, and TR1501924.  
FEI Number 2024094
Recalling Firm/
Manufacturer		 Millipore Corporation
28820 Single Oak Dr
Temecula CA 92590-3607
For Additional Information Contact
951-676-8080
Manufacturer Reason
for Recall		Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
FDA Determined
Cause 2		Pending
ActionMillipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail. Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.
Quantity in Commerce404 units
DistributionWorldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
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.
510(K) Database510(K)s with Product Code = GNW
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