Devices

Device Recall Staphytect Plus

Model / Serial
100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010; 500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
Product Description
Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). 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.
Manufacturer
Remel, Inc
1 Event
- Recall of Device Recall Staphytect Plus

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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