Meridian Bioscience Inc: 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.

Recall number

Z-0203-2012

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.

Status

Terminated

Initiated

2011-10-10

Posted

2011-11-17

Terminated

2012-02-19

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K953362"]

PMA numbers

not on file

Product code

LFX

Firm FEI

1524213

Firm city

Cincinnati

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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