Recall Z-1842-2015— Remel Inc

Name: FDA recall Z-1842-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-19

Class II · Terminated

Class II FDA medical device recall by Remel Inc, initiated 2015-05-19, terminated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.. Reason: Use of the recalled product may result in false positive reports..

Recalling firm: Remel Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-19
Terminated: 2017-03-24
Firm location: Lenexa, KS, United States

Product description

VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.

Reason for recall

Use of the recalled product may result in false positive reports.

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