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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Legionella Pneumo Groups 214

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  Class 2 Device Recall Oxoid Legionella Pneumo Groups 214 see related information
Date Initiated by Firm March 17, 2014
Date Posted April 18, 2014
Recall Status1 Terminated 3 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/
Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Earleen C. Parks
Manufacturer Reason
for Recall
A reagent contained within the product may return false negative results.
FDA Determined
Cause 2
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.