—#78760

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.

FDA product code: GTQ — Antistreptolysin - Titer/Streptolysin O Reagent
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide Distribution -- USA and Canada.

Timeline

Recall initiated: 2008-11-18
Posted by FDA: 2009-05-19
Terminated: 2009-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #78760. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.