CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

Premier Ehec and Premier Ehec Bulk recalled by Meridian Bioscience

Meridian Bioscience is recalling Premier Ehec and Premier Ehec Bulk, distributed in 38 states. The recall was initiated on 8 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPREMIER EHEC Product Code 608096: 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, Lot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk Product Code 608096BU: 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.

Quantity recalled4,747 EHEC + 180 EHEC Bulk

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1033-2017
FDA event ID: 75651
Recalling firm: Meridian Bioscience, Cincinnati, OH
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2016
FDA classified: 17 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Nov 2016	Recall initiated by company
17 Jan 2017	Classified by FDA	+70 days
25 Jan 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

PREMIER EHEC and PREMIER EHEC Bulk.

Where it was distributed

Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.

Alabama Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi Montana

Questions about this recall

Why was it recalled?

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

Which lots are affected?

PREMIER EHEC Product Code 608096: 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, Lot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk Product Code 608096BU: 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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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