Z-0203-2012

EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot#...

Name: Z-0203-2012 EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot#...
Creator: Meridian Bioscience Inc
Published: 2011-10-10
License: https://open.fda.gov/license/

Meridian Bioscience Inc / initiated 2011-10-10 / Terminated / root cause: manufacturing process

FDA source

Meridian Bioscience Inc began a recall of EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot#... on 2011-10-10. The reason FDA records is "Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0203-2012
Status: Terminated
Initiated: 2011-10-10
Posted: 2011-11-17
Terminated: 2012-02-19
Recalling firm: Meridian Bioscience Inc
Product: EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections.
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall: Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Meridian Bioscience, Inc. sent an Urgent Medical Device Recall letter dated October 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, evaluate testing performed with the affected product., and segregate and destroy remaining inventory. Customers were asked to contact Meridian's Technical Service Department by phone or facsimile as necessary. For replacement product phone 800-343-3858, outside North America 513-271-3700, Fax 513-272-5432. Customers were also asked to complete and return the attached Customer Response Form. In the event that they have no remaining inventory, customers were instructed to indicate such on the Customer Response Form and return to Meridian Technical Service. For questions phone 800-343-3858, outside North America 513-271-3700.
Quantity in commerce: 3236 Kits
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI and WV and the countries of AUSTRALIA, CANADA, CHILE, COSTA RICA, ITALY, JAPAN and NEW ZEALAND.
Product codes and lots: Lot# 608096, Lot# 8602 EXP.1, Lot# 2607 EXP.2, Lot# 8603 EXP.3, Lot# 8604 EXP.4, Lot# 1601 EXP.5, Lot# 1601 EXP.6, Lot# 8601 EXP.7, Lot# 1603 EXP.8

Product code LFX

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)