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U.S. Department of Health and Human Services

Class 2 Device Recall Staphytect Plus

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  Class 2 Device Recall Staphytect Plus see related information
Date Initiated by Firm July 20, 2009
Date Posted February 23, 2010
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0818-2010
Recall Event ID 53553
Product Classification Kit, screening, staphylococcus aureus - Product Code JWX
Product Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK.

Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
Code Information 100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010;  500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Debbie Wyatt
913-895-4075
Manufacturer Reason
for Recall		 The products may give false positive results with some non-Staphylococcus aureus strains
FDA Determined
Cause 2		 Process control
Action Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail. For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
Quantity in Commerce 50 boxes (47 DR0850M; 3 DR0850B)
Distribution Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
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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