—#85853

Product

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 product code: JWX — Kit, Screening, Staphylococcus Aureus
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: 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

Why it was recalled

The products may give false positive results with some non-Staphylococcus aureus strains

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.

Timeline

Recall initiated: 2009-07-20
Posted by FDA: 2010-02-23
Terminated: 2012-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85853. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.