Athens, OH, United States
Diagnostic Hybrids, Inc. recalls
4 recalls recorded since 2018, most recently on 4 April 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 April 2017
- Terminated
- 28 August 2020
- Reason
- There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
- Distribution
- The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1496-2018
- 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
Terminated Class III Medical devices
- Recall started
- 26 October 2016
- Terminated
- 28 August 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1520-2018
- Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Terminated Class II Medical devices
- Recall started
- 14 July 2016
- Terminated
- 28 August 2020
- Reason
- There is a possibility of low volume and/or leaking standard bottles.
- Distribution
- The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Sw
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1797-2018
- MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Terminated Class III Medical devices
- Recall started
- 3 November 2015
- Terminated
- 28 August 2020
- Reason
- A component of the kit was found to contain bacterial contamination.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1499-2018, Z-1498-2018, Z-1497-2018
- MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
- MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
- 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 (CI
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.