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Diagnostic Hybrids, Inc. recalls Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone
Recalled May 2, 2018 · FDA recall Z-1520-2018 · Diagnostic Hybrids
Hazard
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. · FDA Class III
Units
26
Sold at
The product was distributed to the following countries: Singapore, Switzerland
Description
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.
Product
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Manufacturer(s)
Diagnostic Hybrids, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →