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.
FDA Recall Z-0818-2010 · Posted 2010-02-23
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Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeJWX
Date Initiated2009-07-20
Date Terminated2012-04-25
Product Quantity50 boxes (47 DR0850M; 3 DR0850B)
Reason for Recall
The products may give false positive results with some non-Staphylococcus aureus strains
Firm Action
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.
For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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