Class 2 Device Recall LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent

• Date Initiated by Firm: November 24, 2008
• Date Posted: March 06, 2009
• Recall Status: Terminated on August 10, 2012
• Recall Number: Z-0954-2009
• Recall Event ID: 50511
• 510(K)Number: K974302
• Product Classification: SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
• Product: LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit.
• Code Information: Lot Numbers JBC1531414, TR1458084, TR1480746, JBC1531421, JH1534500, TR1501923, TR1417106, and TR1422506.
• 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: Pending
• Action: Millipore 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 Commerce: 258 units
• Distribution: Worldwide 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = GNW