Remel, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Remel, Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Remel, Inc is recalling Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 due to The products may give false positive results with some non-Staphylococcus aureus strains. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The products may give false positive results with some non-Staphylococcus aureus strains
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026