—#75004

Product

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 product code: JWX — Kit, Screening, Staphylococcus Aureus
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K972030
Affected lot / code info: Lot J054710, Exp. 2010.04.30

Why it was recalled

Control and test wells are reversed on some of the reaction cards.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including MN, MI, IL, and NC.

Timeline

Recall initiated: 2008-10-07
Posted by FDA: 2009-03-20
Terminated: 2009-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75004. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.