Premier EHEC Kit 의 리콜

Recall

60124

Class 2

Z-0203-2012

2011-10-10

2011-11-17

Terminated

United States

2012-02-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104483

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.

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.