Recall Z-1033-2017— Meridian Bioscience Inc

Name: FDA recall Z-1033-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-08

Class II · Terminated

Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2016-11-08, terminated 2017-08-16. It names one FDA 510(k) clearance: K953362. Product: PREMIER EHEC and PREMIER EHEC Bulk.. Reason: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens..

Recalling firm: Meridian Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Terminated: 2017-08-16
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K953362 — PREMIER EHECMeridian Diagnostics, Inc.·cleared 1995-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PREMIER EHEC and PREMIER EHEC Bulk.

Reason for recall

Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

Data sourced from openFDA. This site is unofficial and independent of the FDA.