Reported Mar 15, 2017 · Terminated

Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,

Remel Inc.

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: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519

Is this the product you have?

  • Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Lot codes and dates
  • A) Lot
    • 978596
    • 2017-01-30
  • B) Lot
    • 978948
    • 2017/01/30
Amount recalled
RO4033 - 163, R01503 - 50.

Where it was sold

Why it was recalled

Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.

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 May 1, 2019 · Data as of Sep 19, 5:30 PM UTC

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