Thermo Fisher recalls remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for…

Recall date

May 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2137-2018

FDA classification

Class II

Brand / firm

Thermo Fisher

Sold / distributed

US Nationwide Distribution

Why it was recalled

Product may fail performance testing for S aureus ATCC 43300.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).