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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Legionella Latex Test

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  Class 2 Device Recall Oxoid Legionella Latex Test see related information
Date Initiated by Firm October 23, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on January 22, 2015
Recall Number Z-0465-2015
Recall Event ID 69566
Product Classification Device, general purpose, microbiology, diagnostic - Product Code LIB
Product Oxoid Legionella Pneumo Groups 2-14 Latex Test, 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, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.
Code Information DR0802M box lot 1301909, Exp. 30Sep2014  
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 within the test may return false negative results.
FDA Determined
Cause 2		 Other
Action ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce 2/50 test boxes
Distribution Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.
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.
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