Devices

Device Recall Staphaurex Plus Kit

Model / Serial
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
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- USA and Canada.
Product Description
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.
Manufacturer
Remel, Inc
1 Event
- Recall of Device Recall Staphaurex Plus Kit

Manufacturer

Remel, Inc

Manufacturer Address
Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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