Z-1497-2018Class III

MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes...

Name: Z-1497-2018 MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes...
Creator: Diagnostic Hybrids, Inc.
Published: 2015-11-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-11-03 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids, Inc. began a recall of 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... on 2015-11-03. FDA classified it as Class III and gives the reason as "A component of the kit was found to contain bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1497-2018
Classification: Class III
Status: Terminated
Initiated: 2015-11-03
Posted: 2018-04-24
Terminated: 2020-08-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: DAK Complement C1q, Antigen, Antiserum, Control
Reason for recall: A component of the kit was found to contain bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.
Quantity in commerce: 19 kits
Distribution: Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Product codes and lots: Lot 051076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24
Z-1498-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24
Z-1499-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

Product code DAK

K862649Class IICytotech Cic Enzyme ImmunoassayCytotech, Inc. / cleared 1986-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)