Date Initiated by Firm |
October 07, 2008 |
Date Posted |
March 20, 2009 |
Recall Status1 |
Terminated 3 on July 30, 2009 |
Recall Number |
Z-1008-2009 |
Recall Event ID |
50224 |
510(K)Number |
K972030
|
Product Classification |
Staphylococcus Aureus Screening Kit - Product Code JWX
|
Product |
Dryspot (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 Contact |
Robert 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 |
Action |
The 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 Commerce |
32 kits dist. by recalling firm |
Distribution |
Nationwide Distribution -- including MN, MI, IL, and NC. |
Total Product Life Cycle |
TPLC Device Report
|
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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) Database |
510(K)s with Product Code = JWX and Original Applicant = OXOID, LTD.
|