Z-1033-2017Class II

PREMIER EHEC and PREMIER EHEC Bulk

Name: Z-1033-2017 PREMIER EHEC and PREMIER EHEC Bulk
Creator: Meridian Bioscience Inc
Published: 2016-11-08
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2016-11-08 / Terminated

FDA source

Meridian Bioscience Inc began a recall of PREMIER EHEC and PREMIER EHEC Bulk on 2016-11-08. FDA classified it as Class II and gives the reason as "Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1033-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Posted: 2017-01-17
Terminated: 2017-08-16
Recalling firm: Meridian Bioscience Inc
Product: PREMIER EHEC and PREMIER EHEC Bulk.
Product code: GNA Antisera, All Types, Escherichia Coli
Reason for recall: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
FDA root cause: Under Investigation by firm
Action: On November 7, 2016 the firm sent Voluntary Medical Device Recall Letters and reply forms to their customers.
Quantity in commerce: 4,747 EHEC + 180 EHEC Bulk
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1033-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17

Product code GNA

K953362Class IPremier EhecMeridian Diagnostics, Inc. / cleared 1995-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)