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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 Plussee related information
Date Initiated by FirmJuly 20, 2009
Date PostedFebruary 23, 2010
Recall Status1 Terminated 3 on April 25, 2012
Recall NumberZ-0818-2010
Recall Event ID 53553
Product Classification Kit, screening, staphylococcus aureus - Product Code JWX
ProductStaphytect 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 ContactDebbie 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
ActionThermo 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 Commerce50 boxes (47 DR0850M; 3 DR0850B)
DistributionNationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
Total Product Life CycleTPLC 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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