Recall Register

Diagnostic Hybrids, Inc.: FDA recalls

FDA enforcement reports name Diagnostic Hybrids, Inc. as the recalling firm in 6 events. The events have 8 product records. The recalls started from 2012 to 2017. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

6 events, newest first.

FDA enforcement events of Diagnostic Hybrids, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
4 Apr 2017MicroVue 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…DeviceClass II1Terminated
26 Oct 2016Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.DeviceClass III1Terminated
14 Jul 2016MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.DeviceClass II1Terminated
3 Nov 2015MicroVue 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…DeviceClass III3Terminated
16 Oct 2014MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.DeviceClass II1Terminated
31 Dec 2012Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.DeviceClass III1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Diagnostic Hybrids, Inc.: events for each product type
TypeEvents
Device6
Diagnostic Hybrids, Inc.: events in each class
ClassEvents
Class II3
Class III3
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Diagnostic Hybrids, Inc., by the year that the recall started. The largest year is 2016, with 2 events.

Official channels

Cite this page

Recall Register. Diagnostic Hybrids, Inc.: FDA recalls. https://recallregister.com/firm/diagnostic-hybrids-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Diagnostic Hybrids, Inc. have?
Class II: 3 events. Class III: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Diagnostic Hybrids, Inc.?
FDA event 79629, which the firm started on 4 Apr 2017. The first product in the record is: 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…
How many FDA recalls of Diagnostic Hybrids, Inc. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.