Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutin

FDA device recall Z-1400-2009 · posted 2009-05-19 · Terminated

Recall details

Recalling firm

Remel, Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GTQ

Quantity affected

446 kits

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2008-11-18

Date posted

2009-05-19

Date terminated

2009-12-03

Location

Lenexa, KS