Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall Z-1008-2009 · Posted 2009-03-20
Recalling FirmRemel, Inc
Recall StatusTerminated
Product CodeJWX
Date Initiated2008-10-07
Date Terminated2009-07-30
Product Quantity32 kits dist. by recalling firm
Reason for Recall
Control and test wells are reversed on some of the reaction cards.
Firm Action
The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.
Root Cause
Pending
Distribution Pattern
Nationwide Distribution -- including MN, MI, IL, and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.