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Premier EHEC
- Starting date:
- November 8, 2016
- Posting date:
- November 18, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61166
Reason
Meridian has received reports from customers that false positive test results have been obtained with some broth samples using Lots 608096H219, 608096H222, 608096H225 and 608096H226. False positive complaints have been neither reported nor confirmed on direct stool specimens. The rate of false-positive results will vary from laboratory to laboratory and may be dependent on the laboratory's test volume. Kit Lots 608096H222, 608096H224 and 608096H226 were not distributed in Canada.
Affected products
Premier EHEC
Lot or serial number
- 608096H219
- 608096H222
- 608096H225
- 608096H226
Model or catalog number
- 608096
Companies
- Manufacturer
-
Meridian Bioscience Inc.
3471 RIVER HILLS DRIVE
Cincinnati
45244
Ohio
UNITED STATES