Recall Z-1497-2018— Diagnostic Hybrids, Inc.

Name: FDA recall Z-1497-2018
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. It names one FDA 510(k) clearance: K862649. Product: MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.. 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

510(k) clearances named in this recall

1 on FDA's record

K862649 — CYTOTECH CIC ENZYME IMMUNOASSAYCytotech, Inc.·cleared 1986-09-04

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

MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

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.