|
Class 2 Device Recall Oxoid dry Spot Staphytect Plus |
|
Date Initiated by Firm |
July 20, 2009 |
Date Posted |
February 23, 2010 |
Recall Status1 |
Terminated 3 on April 25, 2012 |
Recall Number |
Z-0817-2010 |
Recall Event ID |
53553 |
Product Classification |
Kit, screening, staphylococcus aureus - Product Code JWX
|
Product |
Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. 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 |
Lot Number: J055610, Exp June 2011 |
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 |
27 kits |
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.
|
|
|
|