Reported Jan 25, 2017 · Terminated

PREMIER EHEC and PREMIER EHEC Bulk.

Meridian Bioscience 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: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023

Is this the product you have?

  • PREMIER EHEC and PREMIER EHEC Bulk.
Lot codes and dates

15 of 15 products

Products covered by this recall
Model / numberProduct as published
—Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent
—Lot # 8603.138 Exp Date 9/30/2017
—Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent
—Lot # 8603.14 Exp Date 1/12/2018
—Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent
—Lot # 8603.141 Exp Date 1/29/2018
—Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent
—Lot # 8603.142, Exp Date 2/5/2018 &
—Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent
608096BULot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk
—Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent
—Lot # 8603.138, Exp Date 9/30/2017; Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent
—Lot # 8603.14, Exp Date 1/12/2018 &
—Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent
—Lot # 8603.143, Exp Date 3/22/2018.
Amount recalled
4,747 EHEC + 180 EHEC Bulk

Where it was sold

Why it was recalled

Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

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 Aug 16, 2017 · Data as of Nov 5, 12:39 AM UTC

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