Z-1496-2018Class II

MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in...

Name: Z-1496-2018 MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in...
Creator: Diagnostic Hybrids, Inc.
Published: 2017-04-04
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-04-04 / Terminated

FDA source

Diagnostic Hybrids, Inc. began a recall of MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure... on 2017-04-04. FDA classified it as Class II and gives the reason as "There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1496-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Posted: 2018-04-24
Terminated: 2020-08-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.
Product code: DAK Complement C1q, Antigen, Antiserum, Control
Reason for recall: There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
FDA root cause: Other
Action: Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.
Quantity in commerce: 101 kits
Distribution: The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
Product codes and lots: Lot 084007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1496-2018	Class II	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)