Reported Jun 20, 2018 · Terminated

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

Thermo Fisher

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Thermo Fisher · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519

Is this the product you have?

    • remel SUPERPACK CS/ 500 SEG/FLASK
    • REF R01626
  • Qty50
  • plate labelREMEL
  • MH W/OXACILLIN Product UsageRecommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin)
Lot codes and dates
  • Lot307200
Amount recalled
67 units

Where it was sold

  • Nationwide

Why it was recalled

Product may fail performance testing for S aureus ATCC 43300.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 19, 2018 · Data as of Sep 19, 6:46 PM UTC

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