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U.S. Department of Health and Human Services

Class 3 Device Recall Dryspot (R) Staphytect Plus

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 Class 3 Device Recall Dryspot (R) Staphytect Plussee related information
Date Initiated by FirmOctober 07, 2008
Date PostedMarch 20, 2009
Recall Status1 Terminated 3 on July 30, 2009
Recall NumberZ-1008-2009
Recall Event ID 50224
510(K)NumberK972030 
Product Classification Staphylococcus Aureus Screening Kit - Product Code JWX
ProductDryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
Code Information Lot J054710, Exp. 2010.04.30
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactRobert Booth
913-895-4007
Manufacturer Reason
for Recall		Control and test wells are reversed on some of the reaction cards.
FDA Determined
Cause 2		Pending
ActionThe recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.
Quantity in Commerce32 kits dist. by recalling firm
DistributionNationwide Distribution -- including MN, MI, IL, and NC.
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.
510(K) Database510(K)s with Product Code = JWX
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