Food, drugs, devices › Diagnostic Hybrids, Inc.
Device recall: Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (
Diagnostic Hybrids, Inc. (Athens, OH) initiated this device recall on 26 Oct 2016; FDA lists 1 product record under event 79595, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 28 Aug 2020. Initiation: voluntary: firm initiated. Diagnostic Hybrids, Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Diagnostic Hybrids, Inc., Athens, OH.
Reason for recall
"There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay."
Distribution
"The product was distributed to the following countries: Singapore, Switzerland"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1520-2018 | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum. | 26 | Class III | Terminated | 2 May 2018 |
Context
Other enforcement events for Diagnostic Hybrids, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Apr 2017 | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum | Device | Class II | 1 |
| 14 Jul 2016 | MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in se | Device | Class II | 1 |
| 3 Nov 2015 | MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in hum | Device | Class III | 3 |
| 16 Oct 2014 | MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic | Device | Class II | 1 |
| 31 Dec 2012 | Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivatio | Device | Class III | 1 |
All 6 events for Diagnostic Hybrids, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "The product was distributed to the following countries: Singapore, Switzerland"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.