🔍 RecallPedia

Diagnostic Hybrids

8 recalls •

🏥 Medical Devices

• Categories: Infusion Pumps, Other Medical Devices, Diagnostic Equipment

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Class I - Dangerous

There is a possibility of low volume and/or leaking standard bottles.

Jul 14, 2016 Infusion Pumps View Details →

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Class I - Dangerous

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.

Oct 26, 2016 Other Medical Devices View Details →

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.

Class I - Dangerous

There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

Apr 4, 2017 Other Medical Devices View Details →

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.

Class I - Dangerous

A component of the kit was found to contain bacterial contamination.

Nov 3, 2015 Infusion Pumps Nationwide View Details →

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.

Class I - Dangerous

A component of the kit was found to contain bacterial contamination.

Nov 3, 2015 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

A component of the kit was found to contain bacterial contamination.

Nov 3, 2015 Infusion Pumps Nationwide View Details →

MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

Class I - Dangerous

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Oct 16, 2014 Diagnostic Equipment View Details →

Diagnostic 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.

Class I - Dangerous

RhMK product fungal contamination.

Dec 31, 2012 Diagnostic Equipment Nationwide View Details →