FDAMay 4, 2018device

remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Product may fail performance testing for S aureus ATCC 43300.

What to do

FDA enforcement status: Terminated

Brands named

thermo fisherthermo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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