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U.S. Department of Health and Human Services

Class 2 Device Recall Staphaurex Plus Kit

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  Class 2 Device Recall Staphaurex Plus Kit see related information
Date Initiated by Firm November 18, 2008
Date Posted May 19, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall Number Z-1400-2009
Recall Event ID 51131
Product Classification Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
Product Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
Code Information Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31;  Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31 
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Debbie Wyatt
913-888-0939
Manufacturer Reason
for Recall		 These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall. When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason for recall. The letter also asked consignees to review their inventories for the product lots indicated and requested that remaining units from the lots be discarded. This letter also had a Product Inventory Checklist enclosed for completion.
Quantity in Commerce 446 kits
Distribution Worldwide Distribution -- USA and Canada.
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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