Class 2 Device Recall Oxoid Legionella Pneumo Groups 214

• Date Initiated by Firm: March 17, 2014
• Date Posted: April 18, 2014
• Recall Status: Terminated on December 11, 2014
• Recall Number: Z-1474-2014
• Recall Event ID: 67777
• Product Classification: General purpose microbiology diagnostic device - Product Code LIB
• Product: Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
• Code Information: DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014
• Recalling Firm/ Manufacturer: Remel Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Earleen C. Parks; 913-895-4185
• Manufacturer Reason for Recall: A reagent contained within the product may return false negative results.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
• Quantity in Commerce: 2/50-test boxes
• Distribution: Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution.
• 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.