Recall Z-1498-2018— Diagnostic Hybrids, Inc.

Name: FDA recall Z-1498-2018
Creator: U.S. Food and Drug Administration
Published: 2015-11-03

Class III · Terminated

Class III FDA medical device recall by Diagnostic Hybrids, Inc., initiated 2015-11-03, terminated 2020-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.. Reason: A component of the kit was found to contain bacterial contamination..

Recalling firm: Diagnostic Hybrids, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-11-03
Terminated: 2020-08-28
Firm location: Athens, OH, United States

Product description

MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Reason for recall

A component of the kit was found to contain bacterial contamination.

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